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CDRH Rare Disease Impact Initiative

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What is the CDRH Rare Disease Impact Initiative?

The Center for Devices and Radiological Health (CDRH) is committed to advancing the development and timely authorization of safe and effective medical devices for individuals living with rare diseases. The CDRH Rare Disease Impact Initiative serves as a centralized effort to facilitate advancing medical devices for patients with rare diseases and address challenges associated with developing devices for patients with rare diseases.

A rare disease is commonly considered to be a disease or condition that affects fewer than 200,000 people in the United States, and many sources of data and information regarding rare diseases are based on that number. More than 30 million people in the United States are living with one of more than 10,000 identified rare diseases, and approximately half of those affected are children. The small patient populations and complex nature of many rare diseases can make medical product development challenging, and many rare diseases currently lack options for diagnosis and treatment.

The initiative intends to promote scientific and regulatory innovation for rare diseases by:

  • Fostering engagement with patients, caregivers, industry, researchers, and the broader rare disease community
  • Identifying unmet medical device needs for people with rare diseases and working with the rare disease community on how CDRH can help address them, including through the development and implementation of relevant regulatory policy and procedures, as needed
  • Helping CDRH review offices consider the unique challenges and complexities of rare diseases in their reviews
  • Strengthening collaboration across the FDA, including the Rare Disease Innovation Hub (RDIH)

Upcoming Events

Rare Disease Innovation, Science, and Exploration (RISE) Workshop

CDRH is pleased to highlight an upcoming Rare Disease Innovation, Science, and Exploration (RISE) Workshop hosted by the Duke Margolis Institute for Health Policy and FDA’s Rare Disease Innovation Hub. The public workshop, RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations, will be held on September 29, 2026 to explore key statistical considerations for rare disease medical product development.

About the Rare Disease Medical Device List

The Rare Disease Medical Device List identifies medical devices authorized for marketing in the United States that are indicated for a rare disease or condition. This list is intended to provide greater visibility and transparency into the current medical device landscape for rare diseases and help advance innovation and development of these devices with the goal of ensuring that medical devices meet the needs of the people living with a rare disease. This list will be updated periodically.

Contents of the Rare Disease Medical Device List:

  • Devices in this list are those that include a rare disease or condition, defined as a disease or condition that affects fewer than 200,000 people in the United States or on National Institutes of Health (NIH) Genetic and Rare Diseases Information Center (GARD) or National Organization for Rare Disorders (NORD) list of rare diseases, in their indications for use. This list does not include Humanitarian Device Exemptions (HDEs) authorized for use in a small population meeting the regulatory eligibility criteria for an HDE but not specifically indicated for use in a rare disease population. This list does not include Emergency Use Authorizations (EUAs).
  • While the National Cancer Institute (NCI) defines rare cancers as those that affect fewer than 40,000 people per year in the United States, this list includes devices with cancer indications that affect fewer than 200,000 people in total in the United States or that are on the NIH GARD or NORD list of rare diseases. 
  • While this list is focused on those devices where a rare disease or condition is included in the indications for use statement of the device, there are other devices that have general intended uses for broad patient populations (for example, certain wheelchairs, radiation therapy, or prosthetic devices) that patients with rare diseases and conditions rely on to significantly improve their quality of life. The FDA recognizes the importance of those devices; however, they are not included in this list because they are not specifically indicated for a rare disease population. 
  • The devices in this list have met the FDA’s applicable premarket review requirements. This review includes an evaluation of whether the available studies are appropriate for the device’s intended use and technological characteristics.
  • A direct link to the FDA’s database entry for each medical device is provided. These entries contain publicly releasable information, such as summaries of safety and effectiveness. Note the summaries are not all inclusive and do not include most of the information that may be submitted in an application.
  • The list is not intended to be comprehensive. The FDA recognizes there are limitations in the approach taken to identify medical devices for rare diseases, and there may be rare diseases and/or devices authorized for rare diseases that are missed and not listed. To address this limitation and to support transparency, the FDA is sharing the process used to identify the medical devices included on this list. See Appendix 1 for additional information on the process used to identify rare disease medical devices on the list. The FDA welcomes feedback from interested parties to help identify additional devices for consideration in future updates. Please reach out to CDRH-Rare@fda.hhs.gov with any questions or feedback on this list.

Rare Disease Medical Device List

Download an Excel File

Rare Disease(s)DeviceManufacturerSubmission NumberDate of Final DecisionLead Review Office
AAT deficiency; Alpha-1 Antitrypsin Deficiency; early-onset primary dystonia; factor XI deficiency; Gaucher disease Type 1; Glucose-6-Phosphate-Dehydrogenase; Deficiency; hereditary hemochromatosis; Inherited thrombophilia due to Factor II (Prothrombin) mutation23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia23AndMe, Inc.DEN16002604/06/2017OHT7
AL amyloidosis; Multiple MyelomaFLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK21062311/18/2022OHT7
AL amyloidosis; light chain deposition disease; Multiple Myeloma; Waldenström’s macroglobulinemiFREELITE HUMAN LAMBDA FREE KITThe Binding Site Group , Ltd.K14039604/16/2014OHT7
AL amyloidosis; light chain deposition disease; Multiple Myeloma; Waldenström’s macroglobulinemiaHUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSERThe Binding Site Group , Ltd.K12005604/01/2013OHT7
AL amyloidosis; light chain deposition disease; Multiple Myeloma; Waldenström’s macroglobulinemiaOptilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free KitThe Binding Site Group , Ltd.K15065808/26/2015OHT7
AL amyloidosis; light chain deposition disease; Multiple Myeloma; Waldenström’s macroglobulinemiaOptilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K17373208/23/2018OHT7
AL amyloidosis; light chain deposition disease; monoclonal gammopathy of undetermined significance; Multiple Myeloma; Waldenström’s macroglobulinemiaOptilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K23129001/24/2024OHT7
AL amyloidosis; light chain deposition disease; monoclonal gammopathy of undetermined significance; Multiple Myeloma; Waldenström’s macroglobulinemiaOptilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K25054905/23/2025OHT7
AL amyloidosis; monoclonal gammopathy of undetermined significance; Multiple MyelomaImmunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT AnalyserThe Binding Site Group , Ltd.K25015910/17/2025OHT7
AL amyloidosis; multiple myelomaFLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK23160102/23/2024OHT7
ANCA associated vasculitisAnti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed)Zeus ScientificK24377605/07/2025OHT7
Acute leukemia, treatment eligibility with REVUFORJ (revumenib) in patients with KMT2A rearrangements on chromosome 11 at location 11q23.3KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)Cytocell LimitedDEN24006709/19/2025OHT7
Acute myelogenous leukemia, treatment eligibility with VANFLYTA (quizartinib) in patients with internal tandem duplication (ITD) mutations and the tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 geneLeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.P160040/S01107/20/2023OHT7
Acute myelogenous leukemia, treatment eligibility with Xospata (gilterinib) in patients with internal tandem duplication (ITD) mutations and the tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 geneLeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.P160040/S00211/28/2018OHT7
Acute myelogenous leukemia, treatment eligibility with midostaurin (RYDAPT®) in patients with internal tandem duplication (ITD) mutations and the tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 geneLeukoStrat CDx FLT3 Mutation AssayInvivoscribe Technologies, Inc.P16004004/28/2017OHT7
Acute myeloid leukemia treatment eligibility with IDHIFA® (enasidenib) in patients with select IDH2 mutationsAbbott RealTime IDH2Abbott Molecular, Inc.P17000508/01/2017OHT7
Acute myeloid leukemia, treatment eligibility with REZLIDHIA (olutasidenib) in patients with select IDH1 mutationsAbbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime IDH1 m2000rt Application CD-ROMAbbott Molecular, Inc.P170041/S00612/01/2022OHT7
Acute myeloid leukemia, treatment eligibility with TIBSOVO® (ivosidenib) in patients with select IDH1 mutationsAbbott RealTime IDH1Abbott Molecular, Inc.P17004107/20/2018OHT7
Addison's diseaseEASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENTMedica Corp.K10108804/04/2011OHT7
Addison's diseaseEASTLYTE NA/K/CA/PHMedica Corp.K11278810/20/2011OHT7
Addison's disease; Cushing syndromePANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYPantex, Div. Bio-Analysis, Inc.K10284105/08/2012OHT7
Addison's disease; bilirubin encephalopathy; cystic fibrosis; kernicterus; pancreatic islet cell carcinomaRAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc.K19224003/27/2020OHT7
Addison's disease; bilirubin encephalopathy; cystic fibrosis; kernicterus; pancreatic islet cell carcinoma; sulfhemoglobinemiaRAPIDPOINT 405 NEONATAL BILIRUBINSiemens Healthcare DiagnosticsK11027708/15/2011OHT7
Addison's disease; bilirubin encephalopathy; cystic fibrosis; kernicterus; pancreatic islet cell carcinoma; sulfhemoglobinemiaRAPIDPOINT 500 BLOOD GAS ANALYERSiemens Healthcare DiagnosticsK11321605/03/2012OHT7
Addison's disease; cystic fibrosisEASYLYTE NA/K/CL/LI ANALYZER, MODEL  2020Medica Corp.K10067304/06/2010OHT7
Addison's disease; cystic fibrosisEASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520Medica Corp.K10082901/14/2011OHT7
Addison's disease; cystic fibrosisELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BVK10264703/24/2011OHT7
Addison's disease; cystic fibrosisPROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.K10295901/14/2011OHT7
Addison's disease; cystic fibrosisPOLY-CHEM 90 ISE MODULEPolymedco, Inc.K11240811/04/2011OHT7
Addison's disease; cystic fibrosisSMARTLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.K12104008/30/2012OHT7
Addison's disease; cystic fibrosisPROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.K12114008/22/2012OHT7
Addison's disease; cystic fibrosisCOBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2Roche DiagnosticsK13241812/18/2013OHT7
Addison's disease; cystic fibrosisGEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorInstrumentation Laboratory COK16022512/14/2016OHT7
Addison's disease; cystic fibrosisAlinity c ICT Sample DiluentAbbott LaboratoriesK17032010/24/2017OHT7
Addison's disease; cystic fibrosisSelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc.K17147602/27/2018OHT7
Addison's disease; cystic fibrosisStat Profile Prime ES Comp Plus Analyzer SystemNova Biomedical CorporationK19136507/19/2019OHT7
Addison's disease; cystic fibrosisSmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K20054410/01/2020OHT7
Addison's disease; cystic fibrosisGLP systems TrackAbbott LaboratoriesK21348603/10/2022OHT7
Addison's disease; cystic fibrosisABL90 FLEX PLUS SystemRadiometer Medicals ApsK25247505/01/2026OHT7
Addison's disease; cystic fibrosis; kernicterus; pancreatic islet cell carcinomaABL90 FLEX PLUSRadiometer Medical ApsK16015311/04/2016OHT7
Addison's disease; cystic fibrosis; kernicterus; pancreatic islet cell carcinomaGEM Premier 5000Instrumentation Laboratory COK17340312/29/2017OHT7
Addison's disease; cystic fibrosis; kernicterus; pancreatic islet cell carcinomaGEM Premier 5000Instrumentation Laboratory COK20379008/20/2021OHT7
Addison's disease; cystic fibrosis; kernicterus; pancreatic islet cell carcinomaGEM Premier 7000 with IQM3Instrumentation Laboratory CompanyK22360808/10/2023OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEX SERIESRadiometer Medical ApsK09268608/06/2010OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEXRadiometer Medical ApsK12019703/19/2012OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEXRadiometer Medical ApsK12264210/26/2012OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEXRadiometer Medical ApsK12272911/16/2012OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEXRadiometer Medical ApsK12374805/07/2013OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEXRadiometer Medical ApsK13014407/31/2013OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaNOVA STAT PROFILE PRIME CCS ANALYZER SYSTEMNova Biomedical CorporationK13170303/25/2014OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL90 FLEX ANALYZERRadiometer Medical ApsK13198809/17/2013OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaSTAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET ANova Biomedical CorporationK14190705/29/2015OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc.K15185608/06/2015OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry AnalyzerBeckman Coulter, Inc.K16183712/16/2016OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaYumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K18337502/12/2019OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerBeckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K22097707/20/2023OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaGEM Premier ChemSTATInstrumentation Laboratory COK22309001/27/2023OHT7
Addison's disease; cystic fibrosis; pancreatic islet cell carcinomaAlinity i Total B-hCG Reagent Kit, Alinity c GlucoseReagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK23079005/19/2023OHT7
Addison's disease; pancreatic islet cell carcinomaCOBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL,COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS BRoche DiagnosticsK11118805/14/2012OHT7
Addison's disease; pancreatic islet cell carcinomaGlucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH,cobas pro integrated solutionsRoche DiagnosticsK19189908/16/2019OHT7
Addison's disease; pancreatic islet cell carcinomacobas pure integrated solutions, Glucose HK Gen.3, ISEindirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSHRoche DiagnosticsK22013409/16/2022OHT7
Addison's disease; pancreatic islet cell carcinomaABL90 FLEX PLUS SystemRadiometer Medicals ApsK24103701/14/2025OHT7
Addison’s disease; cystic fibrosisTrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc.K15176712/11/2015OHT7
Addison’s disease; cystic fibrosisEDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit ControlEdan Instruments, Inc.K15197807/15/2016OHT7
Addison’s disease; cystic fibrosisAtellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)Siemens Healthcare DiagnosticsK16195403/09/2017OHT7
Addison’s disease; cystic fibrosisLIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600Ams DiagnosticsK17223206/12/2019OHT7
Addison’s disease; cystic fibrosisStat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK20040304/14/2020OHT7
Addison’s disease; cystic fibrosisA-LYTE® Integrated Multisensor (IMT Na K Cl)Siemens Healthcare Diagnostics, Inc.K22243807/25/2023OHT7
Aggressive systemic mastocytosis, treatment eligibility with Gleevec (imatininb mesylate) for patients with KIT D816V mutationKIT D816V ASSAYArup LabaratoriesH14000612/18/2015OHT7
Alpha-1 Antitrypsin DeficiencyAlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols CompanyK22142010/27/2022OHT7
Anaplastic thyroid cancer, treatment eligibility with TAFINLAR® (dabrafenib) in combination with MEKINIST® (trametinib) in patients with BRAF V600E mutationsOncomine Dx Target TestLife Technologies CorporationP160045/S02509/29/2023OHT7
Antiphospholipid SyndromeHEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory COK09155605/21/2010OHT7
Antiphospholipid SyndromeCARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEMPhadia US, Inc.K09184506/07/2010OHT7
Antiphospholipid SyndromeHEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLSInstrumentation Laboratory COK09218103/11/2010OHT7
Antiphospholipid SyndromeZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEMZeus Scientific, Inc.K10242512/12/2011OHT7
Antiphospholipid SyndromeBIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETSBio-Rad LaboratoriesK10383403/30/2012OHT7
Antiphospholipid SyndromeELIA  B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.K11241406/22/2012OHT7
Antiphospholipid SyndromeIMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISASImmco Diagnostics, Inc.K11302010/25/2012OHT7
Antiphospholipid SyndromeQUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAInova Diagnostics, Inc.K12081702/26/2013OHT7
Antiphospholipid SyndromeBIOPLEX 2200 APLS IGMBio-Rad LaboratoriesK13052810/21/2013OHT7
Antiphospholipid SyndromeImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K16278806/19/2017OHT7
Antiphospholipid SyndromeEliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia ABK18132906/25/2018OHT7
Antiphospholipid SyndromeACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory COK22135909/29/2023OHT7
Antiphospholipid SyndromeAptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc.K22309312/17/2024OHT7
Antiphospholipid SyndromeAptiva APS IgA ReagentInova Diagnostics, Inc.K24397902/06/2026OHT7
Antithrombin Deficiency; hemophilia A; hemophilia BINNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK24295203/28/2025OHT7
Atrial Septal DefectsGORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.P050006/S06003/30/2018OHT2
Atrial Septal DefectsOcclutech® ASD Occluder and Occlutech® Pistol PusherOcclutech Holding AGP20003212/29/2023OHT2
B-cell acute lymphoblastic leukemia; Chronic Lymphocytic Leukemia; Multiple MyelomaAdaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies CorporationK20000908/05/2020OHT7
B-cell acute lymphoblastic leukemia; Multiple MyelomaAdaptive Biotechnologies clonoSEQ AssayAdaptive Biotechnologies CorporationDEN17008009/28/2018OHT7
B-cell chronic lymphocytic leukemiaVYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34Abbott Molecular, Inc.K10001508/09/2011OHT7
B-cell chronic lymphocytic leukemia, treatment eligibility with VENCLEXTA® (venetoclax) in patients with chromosome 17p deletionsVYSIS CLL FISH PROBE KITAbbott Molecular, Inc.P15004104/11/2016OHT7
B-cell lymphoma; plasma cell neoplasmsVENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)Ventana Medical Systems, Inc.DEN24002512/05/2024OHT7
Bacillus anthracis (anthrax); chikungunya virus; Crimean-Congo hemorrhagic fever; Crimean-Congo hemorrhagic fever virus; dengue virus; Ebolavirus spp. (ebola); Francisella tularensis (tularemia); Lassa virus (lassa); leishmaniasis; Leptospira spp. (leptospirosis); Marburg virus (marburg); Plasmodium spp. (malaria); visceral leishmaniasis; yellow fever virus; Yersinia pestis (plague)BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelBiofire Defense, LLCK21336203/22/2023OHT7
Biliary tract cancer (intrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, extrahepatic cholangiocarcinoma), treatment eligibility with ZIIHERA® in patients with HER2 protein overexpressionPATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.P990081/S05411/20/2024OHT7
Bloom syndrome23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)23AndMeDEN14004402/19/2015OHT7
Bordetella pertussis infection; pertussisAmpliVue Bordetella AssayQuidel CorporationK14320612/10/2014OHT7
Bordetella pertussis infection; pertussisGreat Basin Bordetella Direct TestGreat Basin Scientific, Inc.K17028403/31/2017OHT7
Burkitt's lymphoma; nasopharyngeal carcinomaBIOPLEX 2200 EBV IGG AND SYPHILIS IGGBio-Rad Laboratories, Inc.K12043903/14/2012OHT7
CREST syndrome; dermatomyositis; limited cutaneous systemic sclerosis; mixed connective tissue disease; polymyositis; systemic sclerosisAlegria Flash ENA ScreenZeus ScientificK25040809/19/2025OHT7
CREST syndrome; dermatomyositis; limited cutaneous systemic sclerosis; mixed connective tissue disease; polymyositis; systemic sclerosisAlegria Flash CTD ScreenZeus ScientificK25066610/22/2025OHT7
CREST syndrome; dermatomyositis; mixed connective tissue disease; polymyositis; scleroderma; systemic sclerosisANA-SCREEN WITH MDSSBio-Rad LaboratoriesK11361007/09/2012OHT7
CREST syndrome; dermatomyositis; mixed connective tissue disease; sclerodermaFIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARISBiomedical Diagnostics (Bmd) SAK10260712/03/2010OHT7
CREST syndrome; limited cutaneous systemic sclerosisImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K15155903/11/2016OHT7
CREST syndrome; mixed connective tissue disease; sclerodermaEliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK18235311/27/2018OHT7
Chagas diseaseChagas Detect Plus Rapid TestInBios International, Inc.K16194712/16/2016OHT7
Cholangiocarcinoma, treatment eligibility with PEMAZYRE® (pemigatinib) in patients with FGFR2 fusions and select rearrangementsFoundationOne CDx (F1CDx)Foundation Medicine, Inc.P170019/S01304/17/2020OHT7
Cholangiocarcinoma, treatment eligibility with TIBSOVO® (ivosidenib) in patients with IDH1 single nucleotide variantsOncomine™ Dx Target TestLife Technologies CorporationP160045/S02808/25/2021OHT7
Churg Strauss Syndromes; glomerulonephritis; Goodpasture's syndrome; idiopathic crescentic glomerulonephritis; Wegener's granulomnatosisFIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEMBiomedical Diagnostics (Bmd) SAK10091711/03/2010OHT7
Clostridial Myonecrosis; compartment syndrome; cyanide poisoning; gas gangrene; myonecrosisSECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.K10026804/26/2010OHT1
Clostridial Myonecrosis; compartment syndrome; cyanide poisoning; gas gangrene; myonecrosis; osteomyelitisRSI 4200Reimers Systems, Inc.K10283108/19/2011OHT1
Clostridial Myonecrosis; compartment syndrome; cyanide poisoning; myonecrosis; osteomyelitisSECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.K14055905/30/2014OHT1
Clostridial Myonecrosis; compartment syndrome; cyanide poisoning; myonecrosis; osteomyelitisFESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberFink Engineering Pty, Ltd.K24056911/21/2024OHT1
Congo hemorrhagic fever; Crimean-Congo hemorrhagic fever; Ebola; Lassa virus (lassa); Marburg virus (marburg)Xpert Hemorrhagic FeverCepheidK25365302/20/2026OHT7
Cytomegalovirus (CMV) Infection; rubellaBIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK09258712/03/2010OHT7
DeBakey Type I aortic dissectionsAMDS Hybrid ProsthesisArtivion, Inc.H23000712/04/2024OHT2
Delivery of Remodulin (treprostinil) for the treatment of pulmonary arterial hypertensionRemunity Pump for Remodulin (treprostinil) InjectionDeka Research and DevelopmentK20269012/30/2020OHT3
DengueCDC DENV-1-4 REAL TIME RT-PCT ASSAYCenters for Disease Control and PreventionDEN12001205/24/2012OHT7
Dengue; Dengue fever; Dengue virus infectionDENV DETECT IGM CAPTURE ELISAInbios Intl., Inc.DEN10002004/08/2011OHT7
Dengue; Dengue fever; Dengue virus infectionDENV Detect NS1 ELISAInBios International, Inc.K18147308/27/2018OHT7
Duchenne muscular dystrophyCreatine KinaseRoche Diagnostics Operations (Rdo)K16057005/25/2016OHT7
Duchenne progressive muscular dystrophyADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K16072409/07/2016OHT7
Duchenne-type muscular dystrophyGSP Neonatal Creatine Kinase - MM kitPerkinelmer, Inc.DEN18005612/12/2019OHT7
Duchenne-type muscular dystrophyCPK REAGENTVital Diagnostics (Manufacturing) PtyltdK11241611/09/2011OHT7
Duchenne-type muscular dystrophyACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K11338908/10/2012OHT7
Duchenne-type muscular dystrophyELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK12208308/22/2012OHT7
Duchenne-type muscular dystrophyEASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTMedica Corp.K12380203/01/2013OHT7
Duchenne-type muscular dystrophyEASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIALMedica CorporationK13008005/13/2014OHT7
Duchenne-type muscular dystrophyELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KITElitechgroupK14126507/18/2014OHT7
Duchenne-type muscular dystrophyCreatine Kinase-MBRoche DiagnosticsK16252605/26/2017OHT7
Duchenne-type muscular dystrophyPointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK19129608/11/2020OHT7
Duchenne-type muscular dystrophyVITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK21264801/28/2022OHT7
Duchenne-type muscular dystrophyAccess CK-MBBeckman Coulter, Inc.K23400502/16/2024OHT7
Ebola; Ebola virus diseaseOraQuick Ebola Rapid Antigen TestOraSure Technologies, Inc.DEN19002510/10/2019OHT7
Esophageal squamous cell carcinoma  treatment eligibility with KEYTRUDA (pembrolizumab) based on PD-L1 protein expressionPD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc.P150013/S01607/30/2019OHT7
Fabry disease; Gaucher disease; Krabbe disease; Mucopolyaccharidosis (MPS) Type I disease; Niemann-Pick A/B disease; Pompe diseaseNeoLSD MSMS KitPerkinelmer, Inc.K19026605/03/2019OHT7
Fabry disease; Gaucher disease; Krabbe disease; Mucopolysaccharidosis Type I (MPS I) disease; Niemann-Pick A/B disease; Pompe DiseaseNeoLSD MSMS kitWallac Oy, A Subsidiary of PerkinelmerK17382907/18/2018OHT7
Fabry disease; Gaucher disease; mucopolysaccharidosis; Mucopolysaccharidosis Type I; Pompe diseaseSEEKER SystemBaebies, Inc.DEN15003502/03/2017OHT7
Fallopian tube or primary peritoneal cancer, treatment eligibility with ELAHERE (mirvetuximab soravtansine) based on FOLR1 protein expressionVENTANA FOLR1 (FOLR-2.1) RxDx AssayVentana Medical Systems, Inc.P22000611/14/2022OHT7
Fallopian tube or primary peritoneal carcinoma, treatment eligibility with KEYTRUDA (pembrolizumab) based on PD-L1 protein expressionPD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc.P150013/S03302/10/2026OHT7
Follicular lymphoma, treatment eligibility with  TAZVERIK™ (tazemetostat) in patients with select EZH2 gene mutationscobas® EZH2 Mutation TestRoche Molecular System, Inc.P20001406/18/2020OHT7
GALT deficiencyGSP NEONATALGALT KIT, MODEL 3303-001UPerkinelmer, Inc.K10010106/11/2010OHT7
Gastric or gastroesophageal junction adenocarcinoma, treatment eligibility with Herceptin®(trastuzumab) in patients with HER2 gene amplificationHER2 FISH PHARMDX KITAgilent Technologies Singapore (International) Pte , Ltd.P040005/S00510/20/2010OHT7
Gastric or gastroesophageal junction adenocarcinoma, treatment eligibility with VYLOY (zolbetuximab) based on CLDN18 protein expressionVENTANA CLDN18 (43-14A) RxDx AssayVentana Medical Systems, Inc.P23001810/18/2024OHT7
Gastric or gastroesophageal junction adenocarcinoma, treatment eligiblity with KEYTRUDA® (pembrolizumab) based on PD-L1 protein expressionPD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc.P150013/S02711/07/2023OHT7
Gastrointestinal stromal tumor, treatment eligibility with AYVAKIT™ (avapritinib) in patients with PDGFRA D842V mutationtherascreen PDGFRA RGQ PCR KitQIAGEN GmbHP21000206/29/2023OHT7
Glanzmann’s thrombasthenia; Von Willebrand DiseaseT-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01Fujimori Kogyo, Co., Ltd.K19136402/14/2020OHT7
Goodpasture Syndrome; granulomatosis with polyangiitis; microscopic polyangiitisEliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayPhadia ABK17379203/13/2018OHT7
Goodpasture Syndrome; granulomatosis with polyangiitis; microscopic polyangiitis; Wegener's granulomatosisELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM POPhadia US, Inc.K14022510/27/2014OHT7
Head and neck squamous cell carcinoma, treatment eligibility with KEYTRUDA (pembrolizumab) based on PD-L1 protein expressionPD-L1 IHC 22C3 pharmDxAgilent Technologies, Inc.P150013/S01406/10/2019OHT7
Hepatitis D; Hepatitis D virusLIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)DiaSorin, Inc.DEN25003212/23/2025OHT7
Hirschsprung diseaseNavina Smart System, Navina Classic SystemDentsply SironaK19097711/22/2019OHT3
Hodgkin disease; liver cancer; small cell lung cancerPET Digital GatingGe Medical Systems, LLCK18031804/11/2018OHT8
Influenza A subtype A/H5 (Avian Influenza)CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK11150708/23/2011OHT7
Influenza A subtype A/H5 (Avian Influenza)CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK13055105/22/2013OHT7
Influenza A subtype A/H5 (Avian Influenza)CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANELCenters for Disease Control and PreventionK13250809/23/2013OHT7
Influenza A subtype A/H5 (Avian Influenza)CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and PreventionK17209108/09/2017OHT7
Influenza A subtype A/H5 (Avian Influenza)CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping KitCenters for Disease Control and PreventionK19030203/27/2019OHT7
Influenza A subtype A/H5 (Avian Influenza)CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping KitCenters for Disease Control and PreventionK20037003/10/2020OHT7
Inherited thrombophilia due to Factor II (Prothrombin) mutationcobas Factor II and Factor V TestRoche Molecular Systems, Inc.K17291301/12/2018OHT7
Inherited thrombophilia due to Factor II (Prothrombin) mutationXpert® FII & FVCepheid®K22304602/15/2023OHT7
Inherited thrombophilia due to Factor II (Prothrombin) mutationXpert® FII & FVCepheidK25021802/21/2025OHT7
Ito nevus; nevus of OtaEVO platformQuanta System SpaK15201212/08/2015OHT4
Ito nevus; nevus of OtaDiscovery Pico FamilyQuanta System SpaK16322212/05/2016OHT4
Ito nevus; nevus of OtaDiscovery Pico, Discovery Pico PlusQuanta System SpaK17194507/28/2017OHT4
Ito nevus; nevus of OtaDiscovery Pico, Discovery Pico PlusQuanta System SpaK17237610/19/2017OHT4
Ito nevus; nevus of OtaDiscovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System SpaK19184209/17/2019OHT4
Ito nevus; nevus of OtaEVO PlatformQuanta System SpaK19216009/06/2019OHT4
Ito nevus; nevus of OtaDiscovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System SpaK24098306/06/2025OHT4
Kaposi sarcomaDIOLASE 10SBiolase Technology, Inc.K12132702/01/2013OHT4
Kaposi sarcomaEPIC 10SBiolase Technology, Inc.K13046504/11/2013OHT4
Kaposi's sarcomaSENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMSensus HealthcareK13158208/28/2013OHT8
Kaposi's sarcoma; Merkel Cell CarcinomaESTEYANucletron B.V.K13209209/26/2013OHT8
Kaposi's sarcoma; Merkel Cell CarcinomaPhotoelectric Therapy SystemXstrahl, Ltd.K17208009/29/2017OHT8
Kaposi's sarcoma; Merkel Cell CarcinomaX80 / RADiant / PhotoElectric Therapy System  (RADiant Aura)Xstrahl, Ltd.K23061107/13/2023OHT8
Lambert-Eaton myasthenic syndromeKRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITKronus Market Development Associates, Inc.K11195605/30/2012OHT7
Legionella pneumophila (Legionnaires' disease); Middle East respiratory syndromeFilmArray Pneumonia Panel plusBiofire Diagnostics, LLCK18132411/15/2018OHT7
Legionella pneumophila serogroup 1 infection (Legionnaires' disease)TRU LEGIONELLAMeridian Bioscience, Inc.K11319002/24/2012OHT7
Legionella pneumophila serogroup 1 infection (Legionnaires' disease)TRU LegionellaMeridian Bioscience, Inc.K16327302/21/2017OHT7
Legionella pneumophila serogroup 1 infection (Legionnaires' disease)ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/SK19118403/05/2020OHT7
Low-grade glioma, treatment eligibility with OJEMDA (tovorafenib) in patients with BFRA V600 mutations and BRAF fusionsFoundationOne CDxFoundation Medicine, Inc.P170019/S05401/16/2025OHT7
Lynch syndromeVENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129)  Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary AntibodyVentana Medical SystemsDEN17003010/27/2017OHT7
Lynch syndromeOncoMate MSI Dx Analysis SystemPromega CorporationK20012907/26/2021OHT7
Lynch syndromeIdylla MSI TestBiocartis NVK21118102/27/2023OHT7
MUTYH-associated polyposisMUTYH-Associated Polyposis (MAP)23AndMe, Inc.K18278401/18/2019OHT7
Medullary thyroid cancer, treatment eligibility with RETEVMO® (selpercatinib) in patients with RET mutationsOncomine Dx Target TestLife Technologies CorporationP160045/S03109/21/2022OHT7
Merkel cell carcinomaEsteyaNucletron B.V.K21394201/11/2022OHT8
Metastatic gastric or gastroesophageal junction adenocarcinoma, treatment eligibility with Herceptin® (trastuzumab) in patients with HER2 protein overexpressionHERCEPTESTAgilent Technologies Singapore (International) Pte , Ltd.P980018/S01010/20/2010OHT7
Middle East respiratory syndromeFilmArray Pneumonia Panel plusBiofire Diagnostics, LLCK22260110/27/2022OHT7
Middle East respiratory syndrome; Parainfluenza virus type 3 infectious disease; pertussisFilmArray Respiratory Panel 2 plus (RP2plus)Biofire Diagnostics, LLCDEN17001711/24/2017OHT7
Multiple MyelomaHEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITThe Binding SiteK13255512/20/2013OHT7
Multiple MyelomaHevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUSThe Binding Site Group , Ltd.K15175911/06/2015OHT7
Multiple MyelomaDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme LaboratoriesK15339411/18/2016OHT7
Multiple MyelomaOptilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda KitThe Binding Site Group , Ltd.K16081906/16/2016OHT7
Multiple MyelomaHevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUSThe Binding Site Group , Ltd.K16185410/04/2016OHT7
Multiple MyelomaOptilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group , Ltd.K17261302/15/2018OHT7
Multiple MyelomaDiazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K18143806/26/2018OHT7
Multiple MyelomaDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K21164809/08/2022OHT7
Multiple MyelomaDiazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K22000108/04/2022OHT7
Multiple MyelomaEasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)Stemcell Technologies Canada, Inc.DEN22009011/06/2023OHT7
Myelodysplastic syndrome, treatment eligibility with TIBSOVO® (ivosidenib) in patients with select IDH1 mutationsAbbott RealTime IDH1Abbott Molecular, Inc.P170041/S00710/24/2023OHT7
Myelodysplastic syndrome/myeloproliferative disease, treatment eligibility with Gleevec (imatininb mesylate) for patients with PDGFRB gene rearrangementPDGFRB FISH ASSAYArup LabaratoriesH14000512/18/2015OHT7
Neonatal opioid withdrawal syndrome (NOWS)Prapela SVS hospital bassinet pad (model P01)Prapela, Inc.DEN24003104/04/2025OHT3
Oligodendroglioma and astrocytoma, treatment eligibility with VORANIGO® (vorasidenib) in patients with IDH1 and IDH2 mutationsOncomine Dx Target TestLife Technologies CorporationP160045/S04610/17/2024OHT7
OrthopoxvirusNon-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK18120509/20/2018OHT7
OrthopoxvirusNON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SETCenters for Disease Control and PreventionDEN07000109/21/2018OHT7
OrthopoxvirusNon-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK22165806/10/2022OHT7
OrthopoxvirusNon-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK22183406/24/2022OHT7
OrthopoxvirusNon-variola Orthopoxvirus Real-time PCR Primer and Probe SetCenters for Disease Control and PreventionK22255808/30/2022OHT7
Osler-Weber-Rendu diseaseOpera EvoQuanta System SpaK20204110/15/2020OHT4
Ota and Ito NevusQ-PLUS T+ IPL LASER SYSTEMQuanta System SpaK12316812/20/2012OHT4
Ota and Ito NevusRossoQuanta System SpaK21122802/02/2022OHT4
Ota's NevusQ-SWITCHED ND:YAG LASERBeijing Honkon Technologies Co., Ltd.K13185701/16/2014OHT4
Pancreatic cancer, treatment eligibility with Lynparza™ (olaparib) for patients with deleterious or suspected deleterious germline BRCA variantsBRACAnalysis CDxMyriad Genetic LaboratoriesP140020/S01912/27/2019OHT7
Parainfluenza virus 3ESENSOR RESPIRATORY VIRAL PANELClinical Micro Sensors, Inc.K11373109/10/2012OHT7
Parainfluenza virus type 3 infectious disease; pertussisBioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLCDEN20003103/17/2021OHT7
Parainfluenza virus type 3 infectious disease; pertussisFILMARRAY RP PANELIdaho Technology, Inc.K12026705/15/2012OHT7
Parainfluenza virus type 3 infectious disease; pertussisFILMARRAY RESPIRATORY PANEL (RP)Biofire Diagnostics, Inc.K12362002/11/2013OHT7
Parainfluenza virus type 3 infectious disease; pertussisFilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray SystemBiofire Diagnostics, LLCK14308002/17/2015OHT7
Parainfluenza virus type 3 infectious disease; pertussisVerigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)Nanosphere, Inc.K14365309/04/2015OHT7
Parainfluenza virus type 3 infectious disease; pertussisFilmArray Respiratory Panel (RP) for use with FilmArray TorchBiofire Diagnostics, LLCK16006802/08/2016OHT7
Parainfluenza virus type 3 infectious disease; pertussisFilmArray Respiratory Panel 2 (RP2)Biofire Diagnostics, LLCK17060405/30/2017OHT7
Parainfluenza virus type 3 infectious disease; pertussisQIAstat-Dx Respiratory PanelQIAGEN GmbHK18359705/18/2019OHT7
Parainfluenza virus type 3 infectious disease; pertussisBioCode Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K19248512/23/2019OHT7
Parainfluenza virus type 3 infectious disease; pertussisQIAstat-Dx® Respiratory Panel PlusQIAGEN GmbHK23310005/10/2024OHT7
Parainfluenza virus type 3 infectious disease; pertussisLIAISON PLEX Respiratory Flex AssayLuminex CorporationK23341003/01/2024OHT7
Parainfluenza virus type 3 infectious disease; pertussisQIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel MiniQIAGEN GmbHK25008008/27/2025OHT7
Parainfluenza virus type 3 infectious disease; pertussisBioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K25413905/01/2026OHT7
Preeclampsia with severe featuresB·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemBrahms GmbH, Part of Thermo Fisher ScientificDEN22002705/18/2023OHT7
Preeclampsia with severe featuresElecsys sFlt-1 and Elecsys PlGFRoche DiagnosticsK24145302/07/2025OHT7
Progressive multifocal leukoencephalopathySTRATIFY JCV DXSELECTFocus Diagnostics, Inc.K12098608/16/2012OHT7
Q feverJBAIDS Q FEVER DETECTION KITIdaho Technology, Inc.K10320705/20/2011OHT7
Reye's syndromeSmart External Drain (SED) SystemAqueduct Critical Care, Inc.K17275911/14/2017OHT5
Reye's syndromeSmart External Drain (SED) SystemAqueduct Critical Care, Inc.K18130106/14/2018OHT5
Reye's syndromeDIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK12332002/15/2013OHT7
Reye's syndromeDIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK12367703/07/2013OHT7
Reye's syndromeAmmonia IIRoche Diagnostics Operations (Rdo)K18351702/08/2019OHT7
Scheuermann's diseasePOLARIS SPINAL SYSTEMBiomet Spine (Aka Ebi, LLC)K13374603/12/2014OHT6
Scheuermann's diseasePolaris Spinal SystemBiomet SpineK15197411/13/2015OHT6
Squamous cell carcinoma of the head and neck, may be associated with enhanced survival from OPDIVO® (nivolumab) based on PD-L1 protein expression.PD-L1 IHC 28-8 PHARMDXAgilent Technologies, Inc.P150025/S00309/15/2017OHT7
Synovial sarcoma, treatment eligibility with TECELRA® (afamitresgene autoleucel) based on MAGE-A4 protein overexpressionMAGE-A4 IHC 1F9 pharmDxAgilent Technologies, Inc.P23001608/01/2024OHT7
West-Nile encephalitisEUROIMMUN Anti-West Nile Virus ELISA (IgM)Euroimmun Us, Inc.K15330808/12/2016OHT7
Zika virus infectionZIKV Detect 2.0 IgM Capture ELISAInBios International, Inc.DEN18006905/23/2019OHT7
Zika virus infectionADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality ControlSiemens Healthcare Diagnostics, Inc.K19157807/17/2019OHT7
Zika virus infectionLIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetDiaSorin, Inc.K19204610/28/2019OHT7
Zika virus infectionDPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro ReaderChembio Diagnostic SystemsK20050606/03/2020OHT7
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEMLumenisK10041504/21/2010OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratDUAL SWITCHLaser Engineering, Inc.K14190810/22/2014OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratThe UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchLumenis, Ltd.K15133106/30/2015OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratCO2RE SystemSyneron Medical, Ltd.K15165509/15/2015OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratAcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOLumenis, Ltd.K18059704/03/2018OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratSyneron CO2RE SystemSyneron-Candela CorpK18152307/11/2018OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratCellene CO2 Laser SystemBio-Med USA, Inc.K18227011/02/2018OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratUltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.K20354412/24/2020OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratAcuPulse CO2 Laser System, Delivery Devices and AccessoriesLumenis, Ltd.K21270310/19/2021OHT4
acoustic neuroma; bowenoid papulosis; choanal atresia; erythroplasia of QueyratAlma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc.K25007109/24/2025OHT4
acute leukemia; myelodysplastic syndrome; myeloma; non-Hodgkin lymphomaClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman CoulterDEN16004706/29/2017OHT7
acute leukemia; myelodysplastic syndrome; myeloma; non-Hodgkin lymphomaClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman CoulterK18359203/21/2019OHT7
acute leukemia; myelodysplastic syndrome; myeloma; non-Hodgkin lymphomaDxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc.K23260011/22/2023OHT7
acute myeloid leukemiaVYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020Abbott Molecular, Inc.K09196008/29/2011OHT7
acute myeloid leukemia; myelodysplastic syndromeVYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)Abbott Molecular, Inc.DEN13001007/29/2013OHT7
acute myeloid leukemia; myelodysplastic syndromeMLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe KitCytocell, Ltd.DEN17007012/21/2018OHT7
acute myeloid leukemia; myelodysplastic syndromeVYSIS D7S486/CEP 7 FISH PROBE KITAbbott Molecular, Inc.K13150809/13/2013OHT7
adhesive arachnoiditis; arachnoiditis; causalgia; complex regional pain syndrome; reflex sympathetic dystrophyProspera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote ManagementBiotronik Nro, Inc.P21003703/31/2023OHT5
adhesive arachnoiditis; arachnoiditis; causalgia; complex regional pain syndrome; reflex sympathetic dystrophyRESTORESENSOR RECHARGABLE IMPLANTABLE NEUROSTIMULATION SYSTEMMedtronic NeuromodulationP840001/S18511/03/2011OHT5
adhesive arachnoiditis; arachnoiditis; causalgia; complex regional pain syndrome; reflex sympathetic dystrophySURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEMMedtronic NeuromodulationP840001/S21903/20/2013OHT5
adhesive arachnoiditis; arachnoiditis; causalgia; complex regional pain syndrome; reflex sympathetic dystrophyPain RC Spinal Cord Stimulation System (SCS) SystemMedtronic NeuromodulationP840001/S52701/08/2024OHT5
amyloidInVision Precision Cardiac AmyloidInVision Medical Technology CorporationK24386605/21/2025OHT2
amyloid; frontotemporal dementia; Lewy body dementiaNeuroQ 3.8SyntermedK18007708/16/2018OHT8
amyloidosisEchoGo Amyloidosis (1.0)Ultromics LimitedK24086011/15/2024OHT2
amyloidosisUs2.caEko.Ai Pte Ltd. D/B/A Us2.AiK25015106/20/2025OHT2
amyloidosisECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)Anumana, Inc.K25380104/07/2026OHT2
amyloidosis; Multiple MyelomaN Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbHK17174211/17/2017OHT7
amyloidosis; Multiple MyelomaN Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbHK18209811/01/2018OHT7
amyloidosis; Multiple MyelomaN Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbHK19087905/03/2019OHT7
amyloidosis; monoclonal gammopathy of undetermined significance; Multiple MyelomaN Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbHK19304707/14/2021OHT7
amyotrophic lateral sclerosisNEURX DIAPHRAGM PACING SYSTEM (DPS)Synapse BiomedicalH10000609/28/2011OHT1
amyotrophic lateral sclerosis; Charcot-Marie-Tooth disease; congenital myopathy; hereditary spastic paraplegia; inclusion body myositis; lateral sclerosis; muscular dystrophy; spinal muscular atrophyMedical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K23369505/07/2024OHT5
amyotrophic lateral sclerosis; Charcot-Marie-Tooth disease; congenital myopathy; inclusion body myositis; lateral sclerosis; muscular dystrophy; spinal muscular atrophyHAL for Medical Use(Lower Limb type)Cyberdyne, Inc.K20155910/02/2020OHT5
amyotrophic lateral sclerosis; lateral sclerosis; myasthenia gravisiBSMIorbit Digital Technologies Private LimitedK24383705/16/2025OHT2
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTRUE BEAM, TRUE BEAM STX, EDGEVarian Medical Systems, Inc.K14052809/05/2014OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.K14322412/19/2014OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaVitalBeamVarian Medical Systems, Inc.K15070605/08/2015OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.K16247201/19/2017OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.K17173307/12/2017OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaVitalBeamVarian Medical Systems, Inc.K17201307/28/2017OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.K21397706/03/2022OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.K22383905/22/2023OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.K23131709/12/2023OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.K23287012/21/2023OHT8
anal carcinoma; arterioveneous malformation; chordoma; craniopharyngioma; esophageal cancer; glioma; hemangioblastoma; hodgkin's lymphoma; meningioma; mesothelioma; pediatric arteriovenous malformation; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgiaTrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.K25294810/07/2025OHT8
anal fistulaBioHealx Anal Fistula DeviceSignum Surgical LimitedDEN24000707/01/2024OHT4
anaplastic large cell lymphoma; classical Hodgkin lymphoma; cutaneous T-cell lymphomaVENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K17247105/08/2018OHT7
aneurysmal subarachnoid hemorrhageNeVa VSVesalioH21000409/09/2022OHT5
angiosarcoma; Kaposi's sarcomaAQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERConvatec, Inc.K12127507/25/2012OHT4
angiosarcoma; Kaposi's sarcomaExufiber Ag+Molnlycke Health Care Us, LLCK16037908/25/2016OHT4
angiosarcoma; Kaposi's sarcomaAQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening FiberConvatec LimitedK17367507/20/2018OHT4
angiosarcoma; Kaposi's sarcomaBiatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)Coloplast Corp.K23195303/22/2024OHT4
anthraxThe SensiTox B. anthracis Toxin TestFirst Light Diagnostics, Inc.K23254511/20/2023OHT7
anthrax infectionApplied Biosystems Bacillus anthracis Detection KitMriglobalK18346210/01/2019OHT7
anthrax infectionB. anthracis Real-time PCR AssayCenters for Disease Control and PreventionK19287111/07/2019OHT7
anthrax; anthrax infectionJBAIDS ANTHRAX DETECTION KITBiofire Diagnostics, Inc.K13193008/05/2013OHT7
anthrax; anthrax infectionANTHRACIS REAL-TIME PCR ASSAYCenters For Disease Control and Prevention (CDC)K14042605/22/2014OHT7
anthrax; melioidosis; plague; tularemia; typhus; typhus feverT2 Biothreat PanelT2biosystems, Inc.K23133609/15/2023OHT7
anthrax; pulmonary anthraxActive Anthrax DetectTM Plus Rapid TestInBios International, Inc.DEN22004402/03/2023OHT7
anti-glutamnate receptor (type NMVDA) autoimmune encephalitisEUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEMEuroimmun Us, Inc.K10001709/13/2010OHT7
antiphospholipid syndromeELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYPhadia US, Inc.K13182112/23/2013OHT7
antiphospholipid syndromeQUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.Inova Diagnostics, Inc.K14127402/13/2015OHT7
antiphospholipid syndromeQUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsInova Diagnostics, Inc.K15287512/21/2015OHT7
arachnoiditis; complex regional pain syndromePrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) SystemsBoston Scientific CorpP030017/S27508/11/2017OHT5
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; medulloblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife PerfexionElekta Instrument ABK15115910/29/2015OHT8
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; medulloblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife IconElekta Instrument ABK15156108/04/2015OHT8
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; medulloblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife IconElekta Instrument ABK16044004/20/2016OHT8
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; medulloblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK22204710/26/2022OHT8
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; medulloblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK25039107/02/2025OHT8
arterioveneous malformations; chordoma; craniopharyngioma; glioblastoma; hemangioblastoma; meningioma; pediatric arteriovenous malformations; pediatric craniopharyngioma; pediatric ependymoma; pediatric glioma; pediatric hemangioblastoma; pediatric medulloblastoma; schwannoma; trigeminal neuralgia; vestibular schwannomasLeksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument ABK17378903/30/2018OHT8
aspergillosis; invasive aspergillosisPLATELIA ASPERGILLUS EIA MODEL 62793Bio-RadK09367801/13/2011OHT7
aspergillosis; invasive aspergillosisMycoMEIA Aspergillus AssayPearl Diagnostics, Inc.K24349608/01/2025OHT7
astrocytoma; brain glioma; glioblastoma; gliomaNS-HGlioNeosoma, Inc.K22173809/27/2022OHT8
ataxia syndrome; fragile x-associated primary ovarian insufficiency; fragile X syndromeAmplideX Fragile X Dx & Carrier Screen KitAsuragen, Inc.DEN19002302/21/2020OHT7
autoimmune Addison's disease; autoimmune polyglandular syndrome, type I or IISTEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITKronus Market Development Associates, Inc.K12104612/20/2012OHT7
autoimmune Addison's disease; autoimmune polyglandular syndrome, type I or IISteroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitKronus, Inc.K18060711/23/2018OHT7
autoimmune hepatitis type 2QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsInova Diagnostics, Inc.K16353809/06/2017OHT7
autoimmune hepatitis, type 1EUROIMMUN ANTI-SLA/LP ELISA(LGG)Euroimmun USK11222109/11/2012OHT7
autoimmune hepatitis, type 2EUROIMMUN ANTI-LKM-1 ELISA(LGG)Euroimmun USK11222309/11/2012OHT7
autoimmune systemic vasculitis; microscopic polyangiitisAESKULISA MPO, MODEL 30-7303USAesku DiagnosticsK09186002/23/2010OHT7
avascular necrosisELEOSx™ Limb Salvage SystemOnkos SurgicalDEN21005804/05/2024OHT6
avascular necrosisTornier Pyrocarbon Humeral HeadTornier S.A.S.DEN22001212/16/2022OHT6
avascular necrosisCORIN METAFIX FEMORAL STEMCorin USAK08252502/04/2010OHT6
avascular necrosisMINIHIP STEMCorin USAK08331204/05/2010OHT6
avascular necrosisAPEX ARC HIP STEMOmni Life Science, Inc.K09084504/07/2010OHT6
avascular necrosisSMITH & NEPHEW HIP SYSTEMS WITH HASmith & Nephew, Inc.K09098204/21/2010OHT6
avascular necrosisHIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712Encore Medical L.P.K09195609/28/2010OHT6
avascular necrosisPATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESISSmith & Nephew, Inc.K09209801/22/2010OHT6
avascular necrosisCORMET CEMENTLESS RESURFACING FEMORAL HEADCorin USAK09219804/15/2010OHT6
avascular necrosisRINGLOC + HYBRID ACETABULAR SYSTEMBiomet, Inc.K09323504/30/2010OHT6
avascular necrosisCOCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERSSmith & Nephew, Inc.K09336301/26/2010OHT6
avascular necrosisTRINITY ACETABULAR SYSTEMCorin USAK09347211/23/2010OHT6
avascular necrosisZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEMZimmer, Inc.K09356104/28/2010OHT6
avascular necrosisACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEMAnova Implant Solutions, LLCK09356702/05/2010OHT6
avascular necrosisLONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERSZimmer, Inc.K09384602/04/2010OHT6
avascular necrosisTIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158Omni Life Science, Inc.K09401703/05/2010OHT6
avascular necrosisEXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MMStelkast CompanyK09403503/24/2011OHT6
avascular necrosisMODIFICAITON TO: CARDO MEDICAL HIP SYSTEMCardo Medical Corp.K09404504/22/2010OHT6
avascular necrosisCARDO MEDICAL CERAMIC HIP SYSTEMCardo Medical, Inc.K10000805/18/2010OHT6
avascular necrosisE1 ANTIOXIDANT INFUSED TECHNOLOGYBiomet Manufacturing CorpK10004803/09/2010OHT6
avascular necrosisGENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTSSmith & Nephew, Inc.K10019702/19/2010OHT6
avascular necrosisBIOLOX DELTA CERAMIC FEMORAL HEADSSmith & Nephew, Inc.K10041205/05/2010OHT6
avascular necrosisKLASSIC HD HIP SYSTEMTotal Joint Orthopedics, Inc.K10044512/03/2010OHT6
avascular necrosisASCENSION MODULAR TOTAL SHOULDER SYSTEMAscension Orthopedics, Inc.K10044808/30/2010OHT6
avascular necrosisARCOS INTERLOCKING DISTAL STEMSBiomet Manufacturing CorpK10046912/07/2010OHT6
avascular necrosisSMITH & NEPHEW MDF MODULAR SLEEVESmith & Nephew, Inc.K10048107/15/2010OHT6
avascular necrosisCONSENSUS REVISION KNEE SYSTEMConsensus Orthopedics, Inc.K10054206/24/2010OHT6
avascular necrosisAPEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNKOmni Life Science, Inc.K10055503/29/2010OHT6
avascular necrosisLIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,Lima-Lto S.P.A.K10085812/10/2010OHT6
avascular necrosisPROFEMUR HIP SYSTEM MODULAR NECKSWrightmedicaltechnologyincK10086604/28/2010OHT6
avascular necrosisMOTIVATION KNEE SYSTEMEncore Medical L.P.K10090006/18/2010OHT6
avascular necrosisASCENSION ANKLE FUSION NAIL SYSTEMAscension Orthopedics, Inc.K10092507/12/2010OHT6
avascular necrosisEVOLUTION UNICONDYLAR KNEE SYSTEMWrightmedicaltechnologyincK10097308/10/2010OHT6
avascular necrosis"UNITED STEM, PSA TYPEUnited Orthopedic Corp.K10098106/14/2010OHT6
avascular necrosisTRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITEHowmedica Osteonics Corp.K10107204/11/2011OHT6
avascular necrosisLONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPERZimmer, Inc.K10122912/03/2010OHT6
avascular necrosisLIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,Lima-Lto S.P.A.K10126301/28/2011OHT6
avascular necrosisE1 AVANTAGE HEADBiomet Manufacturing CorpK10133601/14/2011OHT6
avascular necrosisAPEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEADOmni Life Science, Inc.K10145106/22/2010OHT6
avascular necrosisAPEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010Omnlife ScienceK10157506/30/2010OHT6
avascular necrosisUNITED U2 BIPOLAR IMPLANTUnited Orthopedic Corp.K10167010/08/2010OHT6
avascular necrosisDYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000Medshape SolutionsK10193408/03/2011OHT6
avascular necrosisINTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSETOmni Life Science, Inc.K10197609/14/2010OHT6
avascular necrosisAPEX KNEE MODULAR  TIBIA SYSTEMOmnlife ScienceK10199409/28/2010OHT6
avascular necrosisDEPUY GLOBAL UNITE SHOULDER SYSTEMDepuy(Ireland)K10199612/15/2010OHT6
avascular necrosisRESTORATION ACETABULAR WEDGE AUGMENTSHowmedica OsteonicsK10201903/03/2011OHT6
avascular necrosisJOURNEY UNICONDYLAR TIBIAL BASEPLATESSmith & Nephew, Inc.K10206910/05/2010OHT6
avascular necrosisR3 XLPE ANTEVERTED LINERSSmith & Nephew, Inc.K10237001/19/2011OHT6
avascular necrosisEVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyincK10238001/07/2011OHT6
avascular necrosisGMK REVISION KNEE SYSTEMMedacta International S.A.K10243709/24/2010OHT6
avascular necrosisANTERIOR APPROACH HIP SURGERY INSTRUMENTSWrightmedicaltechnologyincK10256512/22/2010OHT6
avascular necrosisFORCE MEDICAL IM NAIL SYSTEMForce Medical, Inc.K10257705/03/2012OHT6
avascular necrosisAPEX PS KNEE SYSTEMOmni Life Science, Inc.K10257803/25/2011OHT6
avascular necrosisTOTAL SHOULDER SYSTEMShoulder Innovations, LLCK10267001/24/2011OHT6
avascular necrosisAEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEMTornier, Inc.K10292401/31/2011OHT6
avascular necrosisAFFINITI TOTAL AND HEMI-SHOULDER SYSTEMTornier, Inc.K10300711/09/2010OHT6
avascular necrosisCORIN BIOLOX DELTA FEMORAL HEADSCorin USAK10312002/28/2011OHT6
avascular necrosisSERIES II X3 LARGE DIAMETER ACCETABULAR INSERTSStryker CorporationK10312411/19/2010OHT6
avascular necrosisGMK REVISION KNEE SC LINERSMedacta International S.A.K10317003/24/2011OHT6
avascular necrosisHIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTSEncore Medical L.P.K10322312/21/2010OHT6
avascular necrosisMODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERTHowmedica Osteonics Corp.K10323302/03/2011OHT6
avascular necrosisSMITH & NEPHEW SMF HIP STEMSmith & Nephew, Inc.K10325601/31/2011OHT6
avascular necrosisANA0TOMICAL SHOULDER TM COMBINED SYSTEMZimmer GmbHK10340403/15/2011OHT6
avascular necrosisCOREN TOTAL HIP SYSTEMCorentec Co., Ltd.K10343107/21/2011OHT6
avascular necrosisARTHREX UNIVERS II SHOULDER PROSTHESISArthrex, Inc.K10346612/22/2010OHT6
avascular necrosisNOVEL TAPERED HIP STEMStryker Corp.K10347903/10/2011OHT6
avascular necrosisTRINITY ACETABULAR SYSTEMCorin USAK10351803/09/2011OHT6
avascular necrosisCONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LIZimmer, Inc.K10366204/15/2011OHT6
avascular necrosis"UNITED" U2 XPE TOTAL KNEE SYSTEMUnited Orthopedic CorporationK10373308/02/2011OHT6
avascular necrosisTAPERLOC COMPLETE, SIZE 5 AND 6Biomet Manufacturing CorpK10375501/21/2011OHT6
avascular necrosisCONSERVE BIO FOAM SHELLWrightmedicaltechnologyincK11002904/19/2011OHT6
avascular necrosisCORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERSCorin USAK11008705/03/2011OHT6
avascular necrosisTAPER OXINIUM FEMORAL HEADSmith & Nephew, Inc.K11010104/11/2011OHT6
avascular necrosisUNITED UTF STEMUnited Orthopedic CorporationK11024508/04/2011OHT6
avascular necrosisEXETER HIP STEMHowmedica Osteonics Corp.K11029009/27/2011OHT6
avascular necrosisGLADIATOR PLASMA CLASSIC HIP STEMWrightmedicaltechnologyincK11039905/10/2011OHT6
avascular necrosisTAPERLOC COMPLETE MICROPLASTY STEMBiomet Manufacturing CorpK11040009/30/2011OHT6
avascular necrosisEAUM TOTAL KNEE SYSTEMCorentec Co., Ltd.K11040402/16/2012OHT6
avascular necrosisVALOR(R) ANKLE FUSION NAIL SYSTEM SCREWWrightmedicaltechnologyincK11055203/23/2011OHT6
avascular necrosisARCOMXL ACTIVE ARTICULATIONBiomet Manufacturing CorpK11055503/24/2011OHT6
avascular necrosisAEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.K11059906/14/2011OHT6
avascular necrosisBIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTIONZimmer, Inc.K11079109/02/2011OHT6
avascular necrosisABG II MONOLITHIC HIP STEMStryker Corp.K11080705/25/2011OHT6
avascular necrosisCLS BREVIUS STEM WITH KINECTIV TECHNOLOGYZimmer GmbHK11083610/07/2011OHT6
avascular necrosisSMR SHOULDER SYSTEM - CTA HUMERAL HEADSLima Corporate S.P.A.K11084707/15/2011OHT6
avascular necrosisAEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEMTornier, Inc.K11086504/27/2011OHT6
avascular necrosisTOTAL SHOULDER SYSTEMShoulder Innovations, LLCK11090505/24/2011OHT6
avascular necrosisZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMENZimmer, Inc.K11094007/01/2011OHT6
avascular necrosisAPEX KNEE SYSTEM, APEX ALL POLY TIBIAOmni Life Science, Inc.K11106207/13/2011OHT6
avascular necrosisAPEX PS KNEE SYSTEM - PS-C INSERTOmni Life Science, Inc.K11118406/22/2011OHT6
avascular necrosisSMR SHOULDER SYSTEM- REVISION STEMSLima Corporate S.P.A.K11121207/28/2011OHT6
avascular necrosisGMK REVISION HYBRID LINERSMedacta InternationalK11128305/27/2011OHT6
avascular necrosisCORIN TRINITY ACETABULAR SYSTEM ECIMA LINERSCorin USAK11148102/06/2012OHT6
avascular necrosisU2 HIP SYSTEMUnited Orthopedic Corp.K11154607/01/2011OHT6
avascular necrosisTOTAL SHOULDER SYSTEMShoulder Innovations, LLCK11159607/05/2011OHT6
avascular necrosisTRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.K11166303/12/2012OHT6
avascular necrosisPROFEMUR(R) E CEMENTLESS HIP STEMWrightmedicaltechnologyincK11169808/19/2011OHT6
avascular necrosisPROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEMWrightmedicaltechnologyincK11169908/19/2011OHT6
avascular necrosisCOMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)Biomet, Inc.K11174612/15/2011OHT6
avascular necrosisEXETER X3 RIMFIT ACETABULAR CUPStryker Corp.K11184810/05/2011OHT6
avascular necrosisBENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUPCorentec Co., Ltd.K11201910/12/2011OHT6
avascular necrosisPRESERVE HIP STEMWrightmedicaltechnologyincK11208012/28/2011OHT6
avascular necrosisH-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSLima Corporate S.P.A.K11209111/09/2012OHT6
avascular necrosisPROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyincK11215011/23/2011OHT6
avascular necrosisMODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADSLima Corporate S.P.A.K11215805/10/2012OHT6
avascular necrosisTITAN MODULAR TOTAL SHOULDER SYSTEMAscension OrthopedicK11243804/11/2012OHT6
avascular necrosis"UNITED" 36MM CERAMIC FEMORAL HEAD, DELTAUnited Orthopedic CorporationK11246309/23/2011OHT6
avascular necrosisADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTSHowmedica Osteonics Corp.K11255609/28/2011OHT6
avascular necrosisAEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.K11261510/11/2011OHT6
avascular necrosisAPEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)Omnlife ScienceK11277912/02/2011OHT6
avascular necrosisPIPELINE TOTAL HIP SYSTEMPipeline OrthopedicsK11280203/09/2012OHT6
avascular necrosisAPEX REVISION KNEE SYSTEMSOmni Life Science, Inc.K11289102/29/2012OHT6
avascular necrosisRENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESISRenovis Surgical Technologies, LLCK11289706/13/2012OHT6
avascular necrosisDELTA TT CUPS, DELTA TT LINERS, BONE SCREWSLima Corporate S.P.A.K11289812/21/2012OHT6
avascular necrosisSMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSLima Corporate S.P.A.K11290006/01/2012OHT6
avascular necrosisKLASSIC KNEE SYSTEMTotal Joint Orthopedics, Inc.K11290602/01/2012OHT6
avascular necrosisANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )Small Bone Innovations, Inc.K11298204/02/2012OHT6
avascular necrosisPROMOS MODULAR SHOULDER SYSTEMSmith & Nephew, Inc.K11301201/05/2012OHT6
avascular necrosisPROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZERWrightmedicaltechnologyincK11301911/10/2011OHT6
avascular necrosisSMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSSmith & Nephew, Inc.K11303801/05/2012OHT6
avascular necrosisSMITH & NEPHEW RADIOPAQUE TRIAL NECKSSmith & Nephew, Inc.K11303910/05/2012OHT6
avascular necrosisSMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWSLima Corporate S.P.A.K11325402/24/2012OHT6
avascular necrosisMETAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K11327105/18/2012OHT6
avascular necrosisCONSERVE THIN SHELLWrightmedicaltechnologyincK11332202/03/2012OHT6
avascular necrosisEVOLUTION MP ADAPTIVE CS INSERTWrightmedicaltechnologyincK11332512/09/2011OHT6
avascular necrosisZIMMER PERSONA KNEE SYSTEMZimmer, Inc.K11336903/27/2012OHT6
avascular necrosisASCEND SHOULDER SYSTEMTornier, Inc.K11341303/09/2012OHT6
avascular necrosisWAGNER CONE PROSTHESIS SYSTEMZimmer GmbHK11355602/17/2012OHT6
avascular necrosisGMK RESUFACING PATELLA SIZE 4Medacta InternationalK11357101/27/2012OHT6
avascular necrosisHIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.K11375603/14/2012OHT6
avascular necrosisMODULAR PROXIMALLY FLUTED HIP STEMSmith & Nephew, Inc.K11378904/19/2012OHT6
avascular necrosisDYNANAIL ANKLE ARTHRODESIS NAILMedShape, Inc.K11382802/29/2012OHT6
avascular necrosisR3 XLPE LINERSSmith & Nephew, Inc.K11384804/27/2012OHT6
avascular necrosisTAPERLOC COMPLETE SIZE 4MM AND XR 123Biomet Manufacturing CorpK12003008/17/2012OHT6
avascular necrosisARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELEDArthrex, Inc.K12004403/08/2012OHT6
avascular necrosisLINEAR HIP STEM, SIZE 5Encore Medical L.P.K12024102/24/2012OHT6
avascular necrosisMETAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTYCorin USAK12036205/04/2012OHT6
avascular necrosisVIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERSZimmer, Inc.K12037006/04/2012OHT6
avascular necrosisDYNA LOCKING ANKLE NAILU&I Corp.K12041905/21/2012OHT6
avascular necrosis"UNITED" U2 FEMORAL COMPONENT, PS, #7United Orthopedic CorporationK12050705/04/2012OHT6
avascular necrosisACCOLADE II HIP STEMHowmedica OsteonicsK12057803/29/2012OHT6
avascular necrosisAEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEMTornier, Inc.K12073907/05/2012OHT6
avascular necrosisGMK - LINE EXTENSIONMedacta InternationalK12079006/08/2012OHT6
avascular necrosisASCEND SHOULDER SYSTEMTornier, Inc.K12079404/13/2012OHT6
avascular necrosisBENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUGCorentec Co., Ltd.K12092409/10/2012OHT6
avascular necrosisMETS SMILES TOTAL KNEE REPLACEMENTStanmore Implants Worldwide , Ltd.K12099209/05/2012OHT6
avascular necrosisLINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8;Encore Medical L.P.K12102406/19/2012OHT6
avascular necrosisMETS MODULAR DISTAL FEMURStanmore Implants Worldwide , Ltd.K12102909/19/2012OHT6
avascular necrosisLOSPA TIBIAL BASE PLATECorentec Co., Ltd.K12103705/03/2012OHT6
avascular necrosisMETS MODULAR TOTAL FEMURStanmore Implants Worldwide , Ltd.K12105509/19/2012OHT6
avascular necrosisMETS MODULAR PROXIMAL FEMURStanmore Implants Worldwide , Ltd.K12105609/20/2012OHT6
avascular necrosisPROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK12122108/09/2012OHT6
avascular necrosisORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.K12129712/28/2012OHT6
avascular necrosisHIP SYSTEMSHowmedica Osteonics Corp.K12130807/30/2012OHT6
avascular necrosisGMK SPHEREMedacta InternationalK12141607/20/2012OHT6
avascular necrosisMETAFIX FEMORAL HIP STEM SIZE 1Corin USAK12143909/14/2012OHT6
avascular necrosisASCEND SHOULDER SYSTEMTornier, Inc.K12149306/20/2012OHT6
avascular necrosisZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMSZimmer, Inc.K12154310/11/2012OHT6
avascular necrosisDYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK12154407/30/2012OHT6
avascular necrosisCORIN TRIFIT TS HIPCorin USAK12156310/05/2012OHT6
avascular necrosisOXFORD ANKLE FUSION NAIL(AFN) SYSTEMOrtho Solutions LimitedK12157509/14/2012OHT6
avascular necrosisSMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEMSmith & Nephew, Inc.K12162710/15/2012OHT6
avascular necrosisBENCOX FORET & BENCOX DELTACorentec Co., Ltd.K12166509/25/2012OHT6
avascular necrosisSMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSmith & Nephew, Inc.K12171409/07/2012OHT6
avascular necrosisMOVATION KNEE SYSTEMEncore Medical L.P.K12172708/15/2012OHT6
avascular necrosisZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.K12177111/07/2012OHT6
avascular necrosisU2 ACETABULAR CUP, PLASMA SPRAYUnited Orthopedic Corp.K12177707/18/2012OHT6
avascular necrosisDOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VEEncore Medical L.P.K12183507/20/2012OHT6
avascular necrosisG7 ACETABULAR SYSTEMBiomet Manufacturing CorpK12187411/23/2012OHT6
avascular necrosisBENCOX II STEM, BENCOX METAL HEADCorentec Co., Ltd.K12209910/05/2012OHT6
avascular necrosisPBP TOTAL HIP SYSTEMPipeline Biomedical Products, LLCK12215812/11/2012OHT6
avascular necrosisAUGMENT AND SCREW, PSA TYPEUnited Orthopedic Corp.K12218302/05/2013OHT6
avascular necrosisU-MOTION II ACETABULAR SYSTEMUnited Orthopedic Corp.K12218502/22/2013OHT6
avascular necrosisADVANCE TOTAL KNEE SYSTEM-PATELLAWrightmedicaltechnologyincK12221803/21/2013OHT6
avascular necrosisGMK NARROWMedacta InternationalK12223209/28/2012OHT6
avascular necrosisFOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATINGEncore Medical L.P.K12223904/11/2013OHT6
avascular necrosisCORIN TRINITY-I ACETABULAR SHELLCorin USAK12230511/21/2012OHT6
avascular necrosisDYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK12238210/22/2012OHT6
avascular necrosisFEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTHUnited Orthopedic CorporationK12250410/10/2012OHT6
avascular necrosisCS2 HIP SYSTEMConsensus Orthopedics, Inc.K12251211/05/2012OHT6
avascular necrosisREVELATION POROUS COATED HIP STEM, SIZE 8Encore Medical L.P.K12263611/02/2012OHT6
avascular necrosisZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMSZimmer, Inc.K12269212/03/2012OHT6
avascular necrosisAEQUALIS ASCEND FLEX SHOULDER SYSTEMTornier S.A.S.K12269801/08/2013OHT6
avascular necrosisZIMMER PERSONA THE PERSONALIZED KNEE SYSTEMZimmer, Inc.K12274512/05/2012OHT6
avascular necrosisPERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.K12276511/09/2012OHT6
avascular necrosisCROSS-OVER ACETABULAR SHELL & LINERStelkast CompanyK12277310/09/2012OHT6
avascular necrosisPROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK12277810/11/2012OHT6
avascular necrosisNOVEL FIT AND FILL STEMHowmedica Osteonics Corp.K12285302/01/2013OHT6
avascular necrosisGKS PRIME FLEX CR TOTAL KNEE SYSTEMPermedicaK12297512/20/2012OHT6
avascular necrosisSMITH & NEPHEW SMF HIP STEMSmith & Nephew, Inc.K12301210/24/2012OHT6
avascular necrosisLONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERSZimmer, Inc.K12301910/22/2012OHT6
avascular necrosisTRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (PHowmedica Osteonics Corp.K12316602/14/2013OHT6
avascular necrosisTK1 TOTAL KNEE SYSTEMNovosource, Inc.K12333904/11/2013OHT6
avascular necrosisPROFEMUR Z CLASSIC STEMSWrightmedicaltechnologyincK12343402/05/2013OHT6
avascular necrosisZIMMER PERSONA TM PERSONALIZED KNEE SYSTEMZimmer, Inc.K12345902/22/2013OHT6
avascular necrosisTRIATHLON TRITANIUM TIBIAL BASEPLATEStrykerK12348605/03/2013OHT6
avascular necrosisOSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTSBiomet, Inc.K12350102/27/2013OHT6
avascular necrosisUTF STEM, REDUCEDUnited Orthopedic CorporationK12355005/01/2013OHT6
avascular necrosisABG III MONOLITHIC HIP STEMHowmedica Osteonics Corp.K12360408/16/2013OHT6
avascular necrosisPROFEMUR TL CLASSIC HIP STEMWrightmedicaltechnologyincK12368802/08/2013OHT6
avascular necrosisPIPELINE KNEE SYSTEMPipeline OrthopedicsK12369205/24/2013OHT6
avascular necrosisTRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLSCorin USAK12370502/12/2013OHT6
avascular necrosisGMK REVISION EXTENSIONMedacta InternationalK12372107/26/2013OHT6
avascular necrosisPICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEMCarboFix Orthopedics , Ltd.K12381006/14/2013OHT6
avascular necrosisTURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+Encore Medical L.P.K12398201/23/2013OHT6
avascular necrosisDEPUY CORAIL AMT HIP PROSTHESISDepuy France S.A.S.K12399109/16/2013OHT6
avascular necrosis611 ANKLE FUSION NAILTornier S.A.S.K13005107/15/2013OHT6
avascular necrosisARCOS TROCHANTER BUTTONBiomet, Inc.K13006304/19/2013OHT6
avascular necrosisMILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGMTgm Medical, Inc.K13008405/03/2013OHT6
avascular necrosisTAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019Encore Medical L.P.K13009906/21/2013OHT6
avascular necrosisTRINITY ACETABULAR SYSTEMCorin MedicalK13012803/08/2013OHT6
avascular necrosisPERSONA NATURAL TIBIA BASEPLATESZimmer, Inc.K13014302/22/2013OHT6
avascular necrosisANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)Small Bone Innovations, Inc.K13014705/03/2013OHT6
avascular necrosisU2 HIP SYSTEM, EXPANDED INDICATIONS FOR USEUnited Orthopedic CorporationK13014906/06/2013OHT6
avascular necrosisPROFEMUR XM DISTAL CENTRALIZERWrightmedicaltechnologyincK13016704/19/2013OHT6
avascular necrosisGMK HINGEMedacta InternationalK13029908/15/2013OHT6
avascular necrosisCORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADSCorin USAK13034305/28/2013OHT6
avascular necrosisPIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)Pipeline OrthopedicsK13035307/01/2013OHT6
avascular necrosisX-ALT HIGHLY CROSS LINKED VE ACETABULAR LINEREncore Medical L.P.K13036509/23/2013OHT6
avascular necrosisDYNASTY ACETABULAR SYSTEM WITH CERAMICWrightmedicaltechnologyincK13037607/03/2013OHT6
avascular necrosisSIRIUS FEMORAL STEMBiomet, Inc.K13061008/30/2013OHT6
avascular necrosisCORIN METAFIX HIP STEMCorin USAK13063405/24/2013OHT6
avascular necrosisSEVIIN SURFACE REPLACEMENT SHOULDERIngen Orthopedics, LLCK13063508/26/2013OHT6
avascular necrosisSMR 3-PEGS GLENOIDSLima Corporate S.P.A.K13064206/12/2013OHT6
avascular necrosisZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.K13066105/09/2013OHT6
avascular necrosisLOSPA TOTAL KNEE REPLACEMENT SYSTEMCorentec Co., Ltd.K13067304/15/2013OHT6
avascular necrosisPROFEMUR RENAISSANCE CLASSIC HIP STEMWrightmedicaltechnologyincK13098405/24/2013OHT6
avascular necrosisLIMACORPORATE SMR CTA HUMERAL HEADSLima Corporate S.P.A.K13111206/07/2013OHT6
avascular necrosisU2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTERUnited Orthopedic CorporationK13111610/30/2013OHT6
avascular necrosisPIPELINE TOTAL HIP SYSTEMPipeline OrthopedicsK13123706/13/2013OHT6
avascular necrosisSEVIIN FRACTURE SHOULDERIngen Orthopedics, LLCK13127708/28/2013OHT6
avascular necrosisEXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMExactech, Inc.K13129811/26/2013OHT6
avascular necrosisGMK FULL PE TIBIAL COMPONENTSMedacta InternationalK13131008/22/2013OHT6
avascular necrosisRENOVIS BIPOLAR HIP SYSTEMRenovis Surgical Technologies, LLCK13135409/19/2013OHT6
avascular necrosisMAK OSS FEMORAL KNEE COMPONENTSBiomet Orthopedics Corp.K13139310/24/2013OHT6
avascular necrosisNOVOKNEE TOTAL KNEE SYSTEMNovosource, Inc.K13139809/16/2013OHT6
avascular necrosisKLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEADTotal Joint Orthopedics, Inc.K13145402/12/2014OHT6
avascular necrosisAPEX KNEE MODULAR TIBIA SYSTEMOmni Life Science, Inc.K13147210/08/2013OHT6
avascular necrosisARTHREX UNIVERS APEXArthrex, Inc.K13163309/27/2013OHT6
avascular necrosisEVOLUTION MP ADAPTIVE PS TIBIAL INSERTWrightmedicaltechnologyincK13167910/23/2013OHT6
avascular necrosisBIOLOX(R) DELTA CERAMIC HEADSBiomet, Inc.K13168410/10/2013OHT6
avascular necrosisU2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENTUnited Orthopedic CorporationK13186401/15/2014OHT6
avascular necrosisCORIN METAFIX HIP STEMCorin USAK13195212/16/2013OHT6
avascular necrosisCORIN MINIHIP STEMCorin USAK13198612/16/2013OHT6
avascular necrosisNOVOHIP TOTAL HIP SYSTEMNovosource, Inc.K13215802/21/2014OHT6
avascular necrosisUTF STEM-REDUCED, ADDITIONAL SIZESUnited Orthopedic CorporationK13220708/30/2013OHT6
avascular necrosisRENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEMRenovis Surgical Technologies, LLCK13231204/11/2014OHT6
avascular necrosisU-MOTION II PS+ CUPUnited Orthopedic Corp.K13245509/03/2013OHT6
avascular necrosisTRIATHLON TRITANIUM METAL-BACKED PATELLAStryker OrthopaedicsK13262411/26/2013OHT6
avascular necrosisPIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)Pipeline BiotechnologyK13262609/19/2013OHT6
avascular necrosisULTRACONGRUENT INSERTUnited Orthopedic CorporationK13275203/13/2014OHT6
avascular necrosisPICCOLO COMPOSITE NAILING SYSTEMCarboFix Orthopedics , Ltd.K13277410/03/2013OHT6
avascular necrosisOSI Q SYSTEM ARTHROSCOPESOrthopedic Sciences, Inc.K13301802/26/2014OHT6
avascular necrosisSMR TT METAL BACK GLENOIDLima Corporate S.P.A.K13334906/03/2014OHT6
avascular necrosisZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.K13337805/12/2014OHT6
avascular necrosisGMK SHORT STEMMedacta InternationalK13363012/20/2013OHT6
avascular necrosisZIMMER(R)  PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSIONZimmer, Inc.K13373702/04/2014OHT6
avascular necrosisKLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUSTotal Joint Orthopedics, Inc.K13383203/13/2014OHT6
avascular necrosisDEPUY GLOBAL UNITE SHOULDER SYSTEMDepuy(Ireland)K13383404/03/2014OHT6
avascular necrosisCONSENSUS VITALITE TIBIAL INSERTConsensus Orthopedics, Inc.K13391907/14/2014OHT6
avascular necrosisU2 FEMORAL COMPONENT, CR, CEMENTEDUnited Orthopedic Corp.K14007306/16/2014OHT6
avascular necrosisU2 FEMORAL COMPONENT, CR, POROUS COATEDUnited Orthopedic Corp.K14007506/13/2014OHT6
avascular necrosisAEQUALIS(TM) ASCENT(TM) FLEX SHOULDER SYSTEMTornier S.A.S.K14008207/18/2014OHT6
avascular necrosisX-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODEDEncore Medical L.P.K14013011/06/2014OHT6
avascular necrosisSAIPH KNEE SYSTEMMatorthoK14022211/17/2014OHT6
avascular necrosisTITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESISBiomet Manufacturing CorpK14039009/10/2014OHT6
avascular necrosisPOROUS COATED COMPREHENSIVE FRACTURE STEMSBiomet Manufacturing CorpK14065207/03/2014OHT6
avascular necrosisG7 OSSEOTI ACETUBLAR SHELLSBiomet, Inc.K14066912/11/2014OHT6
avascular necrosisNOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUGNovosource, Inc.K14070106/27/2014OHT6
avascular necrosisEVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTSMicroport Orthopedics, Inc.K14073508/29/2014OHT6
avascular necrosisGMK SPHERE EXTENSIONMedacta InternationalK14082607/15/2014OHT6
avascular necrosisEXPRT REVISION KNEEEncore Medical L.P.K14083007/11/2014OHT6
avascular necrosisPATIENT SPECIFIC DISTAL FEMORALStanmore Implants Worldwide , Ltd.K14089801/20/2015OHT6
avascular necrosisPATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENTStanmore Worldwide Implants , Ltd.K14090002/12/2015OHT6
avascular necrosisKLASSIC KNEE TIBIAL STEM EXTENSIONTotal Joint Orthopedics, Inc.K14094205/16/2014OHT6
avascular necrosisMASTERSL FEMORAL STEMLima Corporate S.P.A.K14097506/10/2014OHT6
avascular necrosisTORNIER AEQUALIS ADJUSTABLE REVERSE SHOULDER SYSTEMTornier, Inc.K14102906/18/2014OHT6
avascular necrosisTRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTSStryker OrthopaedicsK14105608/05/2014OHT6
avascular necrosisPROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMSMicroport Orthopedics, Inc.K14123509/12/2014OHT6
avascular necrosisMINIMA S SYSTEMLima Corporate S.P.A.K14132708/06/2014OHT6
avascular necrosisBIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)Biomet, Inc.K14133110/27/2014OHT6
avascular necrosisAEQUALIS FX2Tornier S.A.S.K14134511/18/2014OHT6
avascular necrosisRENOVIS CEMENTED HIP SYSTEMRenovis Surgical Technologies, Inc.K14137009/02/2014OHT6
avascular necrosisDELTA TT ACETABULAR SYSTEMLima Corporate S.P.A.K14139506/30/2014OHT6
avascular necrosisORTHOFIX ANKLE HINDFOOT NAILING SYSTEMOrthofix SrlK14157111/12/2014OHT6
avascular necrosisBIOLOX DELTA CERAMIC OPTION HEADSBiomet, Inc.K14165308/18/2014OHT6
avascular necrosisRENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEMRenovis Surgical Technologies, Inc.K14167611/04/2014OHT6
avascular necrosisWrist Hemiarthroplasty SystemArthrosurface, Inc.K14192012/23/2014OHT6
avascular necrosisPHYSICA KR KNEE SYSTEMLima Corporate S.P.A.K14193404/02/2015OHT6
avascular necrosisKLASSIC HD ACETABULAR INSERT WITH E-LINK POLYTotal Joint Orthopedics, Inc.K14197210/09/2014OHT6
avascular necrosisENCORE HUMERAL SHOULDER STEMEncore Medical L.P.K14199011/07/2014OHT6
avascular necrosisGMK EXTENSIONMedacta InternationalK14206912/02/2014OHT6
avascular necrosisPROCOTYL L-O ACETABULAR SYSTEMMicroport Orthopedics, Inc.K14211902/27/2015OHT6
avascular necrosisSMR 40MM GLENOSPHERELima Corporate S.P.A.K14213911/07/2014OHT6
avascular necrosisOMNI Interface Acetabular SystemOmnlife ScienceK14220101/26/2015OHT6
avascular necrosisSirius Femoral Stem, Size 30ABiomet, Inc.K14229509/15/2014OHT6
avascular necrosisAnatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture SystemZimmer GmbHK14240311/24/2014OHT6
avascular necrosisTITAN Modular Total Shoulder SystemAscension OrthopedicsK14241311/14/2014OHT6
avascular necrosisRestoration Anatomic ShellStryker OrthopaedicsK14246211/14/2014OHT6
avascular necrosisEVOLUTION MP Revision Femur, EVOLUTION Femoral AugmentsMicroport Orthopedics, Inc.K14255011/07/2014OHT6
avascular necrosisVALOR Hindfoot Fusion Nail SystemWrightmedicaltechnologyincK14260210/22/2014OHT6
avascular necrosisTrident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.K14260601/26/2015OHT6
avascular necrosisProgressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLCK14264903/24/2015OHT6
avascular necrosisG7 Finned Acetabular ShellBiomet Manufactuting Corp.K14274612/29/2014OHT6
avascular necrosisCorin TaperFit Hip StemCorin USAK14276104/03/2015OHT6
avascular necrosisZimmer Persona Personalized Knee SystemZimmer, Inc.K14278712/22/2014OHT6
avascular necrosisBiomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLCK14281406/25/2015OHT6
avascular necrosisG7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.K14288202/10/2015OHT6
avascular necrosisHemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.K14294212/19/2014OHT6
avascular necrosisEcho Bi-Metric Microplasty Hip SystemBiomet, Inc.K14300912/18/2014OHT6
avascular necrosisStryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior ApproachStryker OrthopaedicsK14308502/09/2015OHT6
avascular necrosisRebel 3DKNEE SystemEncore Medical L.P.K14324205/15/2015OHT6
avascular necrosisSMR Modular GlenoidLima Corporate S.P.A.K14325605/28/2015OHT6
avascular necrosisProgressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLCK14331402/27/2015OHT6
avascular necrosisADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.K14336601/21/2015OHT6
avascular necrosisTriathlon Tritanium Cone AugmentsStryker OrthopaedicsK14339301/13/2015OHT6
avascular necrosisKlassic HD Hip SystemTotal Joint Othopedics, Inc.K14340712/23/2014OHT6
avascular necrosisMasterSL femoral stemLima Corporate S.P.A.K14350901/27/2015OHT6
avascular necrosisKINETIS Total Knee SystemMako SurgicalK14363502/20/2015OHT6
avascular necrosisRenovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.K14364705/11/2015OHT6
avascular necrosisEquinoxe Mega ProsthesisExactech, Inc.K14365904/09/2015OHT6
avascular necrosisModified Bencox Hip SystemCorentec Co., Ltd.K15000705/04/2015OHT6
avascular necrosisZimmer Segmental System XT ComponentsZimmer, Inc.K15002802/06/2015OHT6
avascular necrosisZimmer Persona Personalized Knee SystemZimmer, Inc.K15009005/20/2015OHT6
avascular necrosisKlassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.K15010502/17/2015OHT6
avascular necrosisPROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.K15013304/20/2015OHT6
avascular necrosisPROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.K15030204/10/2015OHT6
avascular necrosisTotal Knee Arthroplasty SystemResponsive Orthopedics, LLCK15049606/12/2015OHT6
avascular necrosisEcho Bi-Metric Microplasty Line ExtensionBiomet, Inc.K15050303/25/2015OHT6
avascular necrosisG7 Dual Mobility SystemBiomet, Inc.K15052205/01/2015OHT6
avascular necrosisProgressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLCK15078306/23/2015OHT6
avascular necrosisREDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.K15079011/16/2015OHT6
avascular necrosisU2 Total Knee System- Additional SizesUnited Orthopedic CorporationK15082909/25/2015OHT6
avascular necrosisU2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic CorporationK15083209/25/2015OHT6
avascular necrosisH-MAX S Femoral Hip SystemLima Corporate S.P.A.K15085510/21/2015OHT6
avascular necrosisRestoration Anatomic ShellStryker OrthopaedicsK15126408/10/2015OHT6
avascular necrosisPhysica CR Knee SystemLima Corporate S.P.A.K15126610/06/2015OHT6
avascular necrosisAequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.K15129309/24/2015OHT6
avascular necrosisU2 Hip Stem, Ti Porous Coated, MatrixUnited Orthopedic CorporationK15131608/13/2015OHT6
avascular necrosisKlassic HD Hip SystemTotal Joint Orthopedics, Inc.K15144009/03/2015OHT6
avascular necrosisIntegra Total Ankle Replacement SystemAscension OrthopedicsK15145908/31/2015OHT6
avascular necrosisArcos One-piece Femoral Revision SystemBiomet, Inc.K15160310/06/2015OHT6
avascular necrosisREDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.K15190209/03/2015OHT6
avascular necrosisPhysica PS Knee SystemLima Corporate S.P.A.K15200810/29/2015OHT6
avascular necrosisBencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone PlugCorentec Co., Ltd.K15208404/29/2016OHT6
avascular necrosisEVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial BaseMicroport Orthopedics, Inc.K15229811/16/2015OHT6
avascular necrosisJOURNEY II Uni Tibial Base and InsertSmith & Nephew, Inc.K15231510/28/2015OHT6
avascular necrosisAll Poly Tibial ComponentUnited Orthopedic CorporationK15243004/12/2016OHT6
avascular necrosisU2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic CorporationK15243904/07/2016OHT6
avascular necrosisZimmer NexGen Complete Knee Solution Tibial and Femoral AugmentsZimmer, Inc.K15249411/25/2015OHT6
avascular necrosisUCP StemUnited Orthopedic CorporationK15253003/14/2016OHT6
avascular necrosisOSS/Arcos IM Total Femur RodBiomet, Inc.K15262110/14/2015OHT6
avascular necrosisMPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K15263103/23/2016OHT6
avascular necrosisCatalyst CSR Shoulder SystemCatalyst Orthoscience, LLCK15282505/11/2016OHT6
avascular necrosisAequalis Fx2Tornier S.A.S.K15296601/14/2016OHT6
avascular necrosisKlassic Knee SystemTotal Joint Orthopedics, Inc.K15307511/13/2015OHT6
avascular necrosisArthrex Univers Apex, Size 5 StemArthrex, Inc.K15311511/23/2015OHT6
avascular necrosisKlassic Knee SystemTotal Joint Orthopedics, Inc.K15331012/17/2015OHT6
avascular necrosisStryker Orthopaedics Hip Systems Labeling UpdateStryker OrthopaedicsK15334505/25/2016OHT6
avascular necrosisCorin Metafix Hip StemCorin U.S.A. LimitedK15338101/21/2016OHT6
avascular necrosisComprehensive SRS/Nexel ElbowBiomet Manufacturing CorpK15339802/03/2016OHT6
avascular necrosisApex Revision Knee SystemOmnilife ScienceK15343712/21/2015OHT6
avascular necrosisSMR 3-Pegs GlenoidsLima Corporate S.P.A.K15372204/06/2016OHT6
avascular necrosisCorin TaperFit Hip StemCorin U.S.A. LimitedK15372503/25/2016OHT6
avascular necrosisCorin TriFit TS HipCorin U.S.A. LimitedK15377203/31/2016OHT6
avascular necrosisH-Max S stemLima Corporate S.P.A.K16001108/22/2016OHT6
avascular necrosisAnatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture SystemZimmer GmbHK16008503/08/2016OHT6
avascular necrosisLOSPA Modular Knee SystemCorentec Co., Ltd.K16015712/01/2016OHT6
avascular necrosisActive-X Total Knee SystemSignature Orthopaedics Pty, Ltd.K16015909/06/2016OHT6
avascular necrosisEMPOWR PS Knee SystemEncore Medical L.P.K16034205/19/2016OHT6
avascular necrosisATTUNE Revision Knee SystemDepuy(Ireland)K16070006/10/2016OHT6
avascular necrosisInitia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical CorporationK16089511/01/2016OHT6
avascular necrosisREDAPT Anteverted Cemented LinerSmith & Nephew, Inc.K16092311/17/2016OHT6
avascular necrosisKlassic HD Hip SystemTotal Joint Othopedics, Inc.K16107310/19/2016OHT6
avascular necrosisArthrex VaultLock GlenoidArthrex, Inc.K16110808/29/2016OHT6
avascular necrosisSMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.K16112002/21/2017OHT6
avascular necrosisiNSitu Total Hip SystemTheken Companies, LLCK16118410/14/2016OHT6
avascular necrosisG7 Dual Mobility System, Active Articulation SystemBiomet, Inc.K16119005/26/2016OHT6
avascular necrosisOXINIUM DH Fermoral HeadsSmith & Nephew, Inc.K16123312/14/2016OHT6
avascular necrosisU2 Total Knee System, PSA Tibial InsertUnited Orthopedic CorporationK16136002/01/2017OHT6
avascular necrosisSMR Shoulder SystemLima Corporate S.P.A.K16147606/24/2016OHT6
avascular necrosisELEOS Limb Salvage SystemOnkos Surgical, Inc.K16152010/28/2016OHT6
avascular necrosisTrident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK16156910/14/2016OHT6
avascular necrosisPersona Partial Knee SystemBiomet, Inc.K16159211/03/2016OHT6
avascular necrosisAnatomical Shoulder Domelock Dome centricZimmer GmbHK16162011/01/2016OHT6
avascular necrosisU2 Total Knee System E-XPE productsUnited Orthopedic CorporationK16170503/16/2017OHT6
avascular necrosisAequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.K16174211/15/2016OHT6
avascular necrosisEXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.K16194509/23/2016OHT6
avascular necrosisAltiVate Anatomic Shoulder SystemEncore Medical L.P.K16202411/21/2016OHT6
avascular necrosisEVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem ExtensionsMicroport Orthopedics, Inc.K16202603/01/2017OHT6
avascular necrosisGMK SphereMedacta International S.A.K16203503/06/2017OHT6
avascular necrosisBencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd.K16212712/05/2016OHT6
avascular necrosisKlassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.K16225610/27/2016OHT6
avascular necrosisREDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.K16230305/01/2017OHT6
avascular necrosisKlassic Knee SystemTotal Joint Orthopedics, Inc.K16242210/28/2016OHT6
avascular necrosisiTotal® Hip Replacement SystemConformis, Inc.K16271906/14/2017OHT6
avascular necrosisExactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.K16290302/27/2017OHT6
avascular necrosisUTF Stem, reduced, #0, #00United Orthopedic CorporationK16319306/08/2017OHT6
avascular necrosisGMK Revision Femoral Distal AugmentationMedacta International S.A.K16331112/21/2016OHT6
avascular necrosisApex Revision Knee SystemOmnilife ScienceK16333204/26/2017OHT6
avascular necrosisSMR Hybrid Glenoid SystemLima Corporate S.P.A.K16339706/29/2017OHT6
avascular necrosisLocking Cage, Full XPE CupUnited Orthopedic CorporationK16344108/25/2017OHT6
avascular necrosisEcofit® Hip SystemImplantcast GmbHK16357709/25/2017OHT6
avascular necrosisResponsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLCK16358506/02/2017OHT6
avascular necrosisSIGN IM NailSign Fracture Care InternationalK16358907/20/2017OHT6
avascular necrosisShotel Ankle Arthrodesis Nail SystemBiopro, Inc.K16362709/14/2017OHT6
avascular necrosisFitmore® Hip StemZimmer GmbHK17007202/07/2017OHT6
avascular necrosisU-Motion II Acetabular System— Additional sizesUnited Orthopedic CorporationK17008910/06/2017OHT6
avascular necrosisBIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular ShellMicroport Orthopedics, Inc.K17028806/15/2017OHT6
avascular necrosisTrinity™ Dual Mobility SystemCorin U.S.A. LimitedK17035910/31/2017OHT6
avascular necrosisPROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.K17044406/26/2017OHT6
avascular necrosisC2 femoral stemLima Corporate S.P.A.K17047311/08/2017OHT6
avascular necrosisPROLIXUS TOTAL KNEE SYSTEMOtis Biotech Co., Ltd.K17053411/09/2017OHT6
avascular necrosisEmpowr CR Knee Tibial InsertEncore Medical L.P.K17057305/31/2017OHT6
avascular necrosisGenius Total Knee SystemSignature Orthopaedics Pty, Ltd.K17061307/17/2017OHT6
avascular necrosisASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbHK17071106/01/2017OHT6
avascular necrosisGLOBAL UNITE Platform Shoulder SystemDepuy Ireland UCK17074801/11/2018OHT6
avascular necrosisAcculoc Total Knee SystemRootloc Co., Ltd.K17075303/23/2018OHT6
avascular necrosisHintermann Series H2 Total Ankle SystemDt Medtech, LLCK17100411/07/2017OHT6
avascular necrosisSmith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.K17107311/21/2017OHT6
avascular necrosisOMNI Anseris Hip StemOmnilife ScienceK17115608/17/2017OHT6
avascular necrosisPROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.K17118108/28/2017OHT6
avascular necrosisDynaNail TTC Fusion SystemMedShape, Inc.K17137611/02/2017OHT6
avascular necrosisEVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.K17138908/08/2017OHT6
avascular necrosisRenovis Surgical Hip Replacement SystemRenovis Surgical TechnologiesK17154311/16/2017OHT6
avascular necrosisTrident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK17176810/02/2017OHT6
avascular necrosisSidus Stem-Free ShoulderZimmer GmbHK17185812/18/2017OHT6
avascular necrosisKlassic HD® Hip SystemTotal Joint Othopedics, Inc.K17196207/24/2017OHT6
avascular necrosisEMPOWR Porous Knee SystemEncore Medical L.P.K17199110/04/2017OHT6
avascular necrosisUTS StemUnited Orthopedic CorporationK17225110/24/2017OHT6
avascular necrosisTriathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker OrthopaedicsK17232610/30/2017OHT6
avascular necrosisGMK Hinge, GMK RevisionMedacta International S.A.K17234711/01/2017OHT6
avascular necrosisAltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket InsertEncore Medical L.P.K17235110/30/2017OHT6
avascular necrosisBone Screws 6.5mmLima Corporate S.P.A.K17245601/04/2018OHT6
avascular necrosisOMNI ARC Anteverted Neck Hip StemOmnilife ScienceK17246712/21/2017OHT6
avascular necrosisiNSitu Total Hip SystemTheken Companies, LLCK17250109/21/2017OHT6
avascular necrosisZimmer Persona Personalized Knee SystemZimmer, Inc.K17252405/17/2018OHT6
avascular necrosisTrinity PLUS Acetabular ShellCorin U.S.A. LimitedK17255106/15/2018OHT6
avascular necrosisTriathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK17263411/16/2017OHT6
avascular necrosisFMP Extended LinersEncore Medical L.P.K17265112/13/2017OHT6
avascular necrosisZimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.K17276711/30/2017OHT6
avascular necrosisBencox Mirabo Cup SystemCorentec Co., Ltd.K17280610/17/2017OHT6
avascular necrosisE-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic CorporationK17283306/12/2018OHT6
avascular necrosisLatitud Hip Replacement SystemMeril Healthcare Pvt. , Ltd.K17285707/19/2018OHT6
avascular necrosisZimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.K17305703/29/2018OHT6
avascular necrosisKlassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc.K17310410/27/2017OHT6
avascular necrosisZimmer Persona Personalized Knee SystemZimmer, Inc.K17341701/30/2018OHT6
avascular necrosisSurgTech Bipolar Head SystemSurgtech, Inc.K17345506/14/2018OHT6
avascular necrosisExeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK17349903/19/2018OHT6
avascular necrosisEMPOWR Universal Tibial BaseplateEncore Medical L.P.K17372303/05/2018OHT6
avascular necrosisBIOLOX delta Option and Extra-long HeadsMicroport Orthopedics, Inc.K17377607/06/2018OHT6
avascular necrosisTRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones SasK17381103/15/2018OHT6
avascular necrosisCatalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.K17381203/09/2018OHT6
avascular necrosisHumeral Short Stem SystemShoulder Innovations, Inc.K17382410/23/2018OHT6
avascular necrosisTriathlon Total Knee SystemStryker OrthopaedicsK17384902/02/2018OHT6
avascular necrosisCorin TriFit CF Hip StemCorin U.S.A. LimitedK17388004/11/2018OHT6
avascular necrosisGMK Sphere - Kinematic AlignmentMedacta International S.A.K17389008/23/2018OHT6
avascular necrosisOVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K17396404/18/2018OHT6
avascular necrosisKlassic® Knee SystemTotal Joint Orthopedics, Inc.K18015903/09/2018OHT6
avascular necrosisEcoFit Vit E Acetabular SystemImplantcast GmbHK18026307/20/2018OHT6
avascular necrosisEVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK SystemMicroport Orthopedics, Inc.K18031705/04/2018OHT6
avascular necrosisb-ONE Total Knee SystemB-One Ortho, Corp.K18044610/12/2018OHT6
avascular necrosisA3 Total Knee SystemBeijing AK Medical Co., Ltd.K18049306/22/2018OHT6
avascular necrosisWorld Knee SystemSignature Orthopaedics Pty, Ltd.K18075004/20/2018OHT6
avascular necrosisPrime Acetabular Cup SystemMicroport Orthopedics, Inc.K18079807/09/2018OHT6
avascular necrosisKlassic HD® Hip SystemTotal Joint Orthopedics, Inc.K18092905/09/2018OHT6
avascular necrosisEMPOWR VVC TIBIAL INSERTEncore Medical L.P.K18093007/09/2018OHT6
avascular necrosisLibertas Hip Replacement SystemMaxx Orthopedics, Inc.K18097309/28/2018OHT6
avascular necrosisASK SystemL and K Biomed Corporation LimitedK18114608/03/2018OHT6
avascular necrosisCatalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.K18128707/12/2018OHT6
avascular necrosisImboki Knee Instrument SystemSignature Orthopaedics Pty, Ltd.K18133801/17/2019OHT6
avascular necrosisAequalis Flex Revive Shoulder SystemTornier, Inc.K18142009/20/2018OHT6
avascular necrosisDelta Dual Mobility SystemLima Corporate S.P.A.K18149105/09/2019OHT6
avascular necrosisArthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.K18155512/21/2018OHT6
avascular necrosisPrime E-CLASS XLPE LinerMicroport Orthopedics, Inc.K18159809/14/2018OHT6
avascular necrosisGMK Sphere CR Tibial InsertsMedacta International S.A.K18163508/23/2018OHT6
avascular necrosisPanta 2 Arthrodesis Nail SystemIntegra LifeSciences CorporationK18163911/02/2018OHT6
avascular necrosisPersona Revision Knee SystemZimmer, Inc.K18194710/25/2018OHT6
avascular necrosisArthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.K18203909/28/2018OHT6
avascular necrosisDelta TT ProLima Corporate S.P.A.K18209912/26/2018OHT6
avascular necrosisREDAPT Modular Acetabular ShellSmith & Nephew, Inc.K18210911/16/2018OHT6
avascular necrosisEVOLUTION Stemmed CS FemurMicroport Orthopedics, Inc.K18212512/06/2018OHT6
avascular necrosisBencox Mirabo Cup Multi HoleCorentec Co., Ltd.K18222104/01/2019OHT6
avascular necrosisEVOLUTION NitrX Medial-Pivot KneeMircoport Orthopedics, Inc.K18225105/16/2019OHT6
avascular necrosisMobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KGK18232105/24/2019OHT6
avascular necrosisAcculoc Total Knee SystemRootloc Co., Ltd.K18237009/27/2018OHT6
avascular necrosisTrident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK18246803/19/2019OHT6
avascular necrosisCatalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.K18250001/11/2019OHT6
avascular necrosisR3 Anteverted LinersSmith & Nephew, Inc.K18253511/19/2018OHT6
avascular necrosisArthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.K18279903/08/2019OHT6
avascular necrosisLINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KGK18287204/03/2019OHT6
avascular necrosisMOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar ComponentB-One Ortho, Corp.K18302501/28/2019OHT6
avascular necrosisSMR Lateralized Connectors with screwsLima Corporate S.P.A.K18304201/25/2019OHT6
avascular necrosisCorin BiPolar-iCorin U.S.A. LimitedK18311406/05/2019OHT6
avascular necrosisMedtronic Total Hip Arthroplasty SystemMedtronic Advanced EnergyK18312907/26/2019OHT6
avascular necrosisZimmer Segmental System Proximal Femoral ComponentZimmer, Inc.K18313601/30/2019OHT6
avascular necrosisStabil Orthopaedic Solutions Total Knee SystemStabil Orthopaedic Solutions, LLCK18322502/15/2019OHT6
avascular necrosisThe Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLCK18334403/18/2019OHT6
avascular necrosisLibertas Acetabular Hooded LinerMaxx Orthopedics, Inc.K18336502/22/2019OHT6
avascular necrosisLatitud Hip Replacement SystemMeril Healthcare Pvt. , Ltd.K18353207/18/2019OHT6
avascular necrosisKlassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link PolyTotal Joint Orthopedics, Inc.K18359603/29/2019OHT6
avascular necrosisLibertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.K18368408/23/2019OHT6
avascular necrosisAequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.K18369601/30/2019OHT6
avascular necrosisDJO Acetabular SystemEncore Medical L.P.K19005706/07/2019OHT6
avascular necrosisJourney II Unicompartmental Knee SystemSmith & Nephew, Inc.K19008502/11/2019OHT6
avascular necrosisMicroPort CoCr Femoral HeadsMicroport Orthopedics, Inc.K19012307/15/2019OHT6
avascular necrosisProvident II Hip StemStelkast, Inc.K19027603/08/2019OHT6
avascular necrosisKlassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link PolyTotal Joint Orthopedics, Inc.K19028003/15/2019OHT6
avascular necrosisAltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.K19029004/26/2019OHT6
avascular necrosisPrecision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc.K19035505/16/2019OHT6
avascular necrosisTriathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)K19040208/22/2019OHT6
avascular necrosisAequalis Ascend Flex Shoulder SystemTornier S.A.S.K19052106/12/2019OHT6
avascular necrosisBiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KGK19053508/06/2019OHT6
avascular necrosisWorld Knee Total Knee SystemsSignature Orthopaedics Pty, Ltd.K19057711/27/2019OHT6
avascular necrosisNanoOrtho NanoKnee® SystemNanoortho, LLCK19063312/20/2019OHT6
avascular necrosisDual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.K19065612/06/2019OHT6
avascular necrosisG7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked PolyethyleneZimmer, Inc.K19066012/05/2019OHT6
avascular necrosisREDAPT Blade AugmentsSmith & Nephew, Inc.K19084710/25/2019OHT6
avascular necrosisConformis BeneFIT Hip SystemConformis, Inc.K19090408/28/2019OHT6
avascular necrosisPhysica KR Liner and SMR Reverse Humeral LinerLimacorporateK19091111/26/2019OHT6
avascular necrosisTriathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)K19099108/15/2019OHT6
avascular necrosisThe Optimotion Blue Total Knee SystemOptimotion Implants, LLCK19108404/07/2020OHT6
avascular necrosisSurgTech GENOLL Total Knee SystemSurgtech, Inc.K19119208/01/2019OHT6
avascular necrosisJOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.K19121107/25/2019OHT6
avascular necrosisAEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.K19131806/14/2019OHT6
avascular necrosisTrident II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK19135810/24/2019OHT6
avascular necrosisBIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.K19139908/28/2019OHT6
avascular necrosisEXETER Centralizer, EXETER 2.5mm PlugStryker OrthopaedicsK19141408/28/2019OHT6
avascular necrosisAGILON® XO Shoulder Replacement SystemImplantcast GmbHK19143311/12/2020OHT6
avascular necrosisZCA All-Poly Acetabular CupsZimmer, Inc.K19144907/16/2020OHT6
avascular necrosisImplantcast ic-Bipolar Head SystemImplantcast GmbHK19156908/28/2019OHT6
avascular necrosisDelta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.K19162211/01/2019OHT6
avascular necrosisPersona Revision Knee SystemZimmer, Inc.K19162509/05/2019OHT6
avascular necrosisPROFEMUR TL2 StemsMicroport Orthopedics, Inc.K19163210/07/2019OHT6
avascular necrosisSMR TT Augmented Glenoid SystemLima Corporate S.P.A.K19174611/22/2019OHT6
avascular necrosisSPAR-K Instruments (for use with Gemini SL Total Knee System)Waldemar Link GmbH & Co. KGK19175507/18/2019OHT6
avascular necrosisOMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.K19176509/25/2019OHT6
avascular necrosisAttune Revision LPS InsertsDepuy(Ireland)K19177910/08/2019OHT6
avascular necrosisWagner SL Revision Stem Lateral and Wagner Cone Prosthesis SystemZimmer GmbHK19178108/06/2019OHT6
avascular necrosisTTC Phantom Intramedullary Nail SystemParagon 28, Inc.K19178209/06/2019OHT6
avascular necrosisCatalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.K19181109/11/2019OHT6
avascular necrosisAlliance GlenoidZimmer, Inc.K19181410/23/2019OHT6
avascular necrosisiNSitu Total Hip SystemThecken Companies, LLCK19193608/20/2019OHT6
avascular necrosisSMR Finned Short StemsLima Corporate S.P.A.K19196310/10/2019OHT6
avascular necrosisiNSitu Total Hip SystemTheken Companies, LLCK19207108/30/2019OHT6
avascular necrosisTTC Phantom® Intramedullary Nail SystemParagon 28, Inc.K19216301/31/2020OHT6
avascular necrosisConformis Hip SystemConformis, Inc.K19219811/06/2019OHT6
avascular necrosisFitmore Hip StemZimmer GmbHK19223611/05/2019OHT6
avascular necrosisShoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.K19236511/29/2019OHT6
avascular necrosisPrecision Casting Solutions Total Hip SystemPrecision Casting Solution, LLCK19245012/17/2019OHT6
avascular necrosisLOSPA II Knee SystemCorentec Co., Ltd.K19250712/11/2019OHT6
avascular necrosisAcetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KGK19255912/21/2019OHT6
avascular necrosisBiolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.K19268302/27/2020OHT6
avascular necrosisZimmer Segmental SystemZimmer, Inc.K19279812/10/2020OHT6
avascular necrosisLibertas E-XLPE Modular LinerMaxx Orthopedics, Inc.K19298910/29/2020OHT6
avascular necrosisComprehensive Shoulder SystemBiomet Manufacturing CorpK19303810/28/2020OHT6
avascular necrosisAlloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbHK19305012/26/2019OHT6
avascular necrosisAnatomical Shoulder SystemZimmer GmbHK19309901/29/2020OHT6
avascular necrosisAlliance Augmented GlenoidZimmer, Inc.K19318002/24/2020OHT6
avascular necrosisPersona Personalized Knee SystemZimmer, Inc.K19322301/24/2020OHT6
avascular necrosisRestoration® Modular Hip SystemHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)K19323305/27/2020OHT6
avascular necrosisPhysica LMC Knee SystemLima Corporate S.P.A.K19328401/31/2020OHT6
avascular necrosisExeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.K19342908/13/2020OHT6
avascular necrosisDistal CentralizersBiomet, Inc.K19354609/25/2020OHT6
avascular necrosisPROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.K20000704/25/2020OHT6
avascular necrosisE-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.K20001110/01/2021OHT6
avascular necrosisZimmer Hip Joint ReplacementZimmer GmbHK20011204/10/2020OHT6
avascular necrosisPersona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial DrillZimmer, Inc.K20015103/17/2020OHT6
avascular necrosisSMR TT Augmented Glenoid SystemLima Corporate S.P.A.K20017111/19/2020OHT6
avascular necrosisTaperloc® Complete Hip StemsBiomet OrthopedicsK20019612/08/2020OHT6
avascular necrosisPersona Personalized Knee SystemZimmer, Inc.K20020903/24/2020OHT6
avascular necrosisTesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K20032803/11/2020OHT6
avascular necrosisLOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.K20039505/07/2020OHT6
avascular necrosisLINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KGK20060705/28/2021OHT6
avascular necrosisAMF Revision TT ConesLima Corporate S.P.A.K20065305/07/2020OHT6
avascular necrosisDelta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.K20065607/08/2020OHT6
avascular necrosisKyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.K20070904/17/2020OHT6
avascular necrosisTriathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-ApatiteHowmedica Osteonics Corp.K20078205/13/2020OHT6
avascular necrosisZimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.K20082307/09/2020OHT6
avascular necrosisBiolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.K20095907/29/2020OHT6
avascular necrosisFusion Taper SystemSignature Orthopaedics Pty, Ltd.K20104704/16/2021OHT6
avascular necrosisPhysica systemLima Corporate S.P.A.K20108412/14/2020OHT6
avascular necrosisPrime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.K20115708/24/2021OHT6
avascular necrosisPhantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.K20122707/17/2020OHT6
avascular necrosisPERFORM Humeral System – StemTornier, Inc.K20131509/11/2020OHT6
avascular necrosisTriathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK20134307/10/2020OHT6
avascular necrosisCadence Total Ankle SystemIntegra LifeSciences CorporationK20150706/29/2020OHT6
avascular necrosisPROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.K20151912/10/2020OHT6
avascular necrosisApex Knee SystemOmnilife ScienceK20161104/02/2021OHT6
avascular necrosisCorin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic HeadsCorin, Ltd.K20165707/28/2021OHT6
avascular necrosisKMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.K20166007/16/2020OHT6
avascular necrosisR3 HA Coated Acetabular ShellsSmith & Nephew, Inc.K20170110/06/2020OHT6
avascular necrosisProvident II Hip StemsGlobus Medical, Inc.K20173307/14/2021OHT6
avascular necrosisEXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.K20185107/30/2020OHT6
avascular necrosisSMR 140° Reverse Humeral BodyLima Corporate S.P.A.K20190512/17/2020OHT6
avascular necrosisGMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)Medacta International S.A.K20202209/18/2020OHT6
avascular necrosisGLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UCK20209811/25/2020OHT6
avascular necrosisAttune Revision Sleeve LPS Femoral AdaptorsDepuy Ireland UCK20224812/28/2020OHT6
avascular necrosisMobio Total Knee SystemB-One Ortho, Corp.K20242910/23/2020OHT6
avascular necrosisCordera Hip SystemConformis, Inc.K20248409/24/2020OHT6
avascular necrosisCatalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.K20261102/12/2021OHT6
avascular necrosisGMK Total Knee System - TiNbN CoatingMedacta International S.A.K20268412/11/2020OHT6
avascular necrosisPrime and DYNASTY® Additive Manufacturing ShellsMicroport Orthopedics, Inc.K20270508/20/2021OHT6
avascular necrosisIgnite Anatomic Shoulder SystemIgnite Orthopedics, LLCK20271605/20/2021OHT6
avascular necrosisKlassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.K20274010/09/2020OHT6
avascular necrosisAltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.K20302612/23/2020OHT6
avascular necrosisELEOS Limb Salvage System featuring BIOGRIPOnkos SurgicalK20309012/11/2020OHT6
avascular necrosisIgnite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLCK20310807/16/2021OHT6
avascular necrosisGlobal Shoulder and Delta CTA systemsDepuy Lnc.K20323004/02/2021OHT6
avascular necrosisEcoFit® Hip SystemImplantcast GmbHK20342002/03/2021OHT6
avascular necrosisKMTI Hip Replacement SystemKyocera Medical Technologies, Inc.K20347204/02/2021OHT6
avascular necrosisEMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.K20355702/10/2021OHT6
avascular necrosisELEOS™ Limb Salvage SystemOnkos SurgicalK20358802/05/2021OHT6
avascular necrosisELEOS Limb Salvage System with BioGripOnkos SurgicalK20381506/09/2021OHT6
avascular necrosisAugmented VaultLock GlenoidArthrex, Inc.K21005006/07/2021OHT6
avascular necrosisEMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.K21030803/30/2021OHT6
avascular necrosisMOBIO Total Knee SystemB-One Ortho, Corp.K21048304/21/2021OHT6
avascular necrosisPersona Revision Knee SystemZimmer, Inc.K21055103/18/2021OHT6
avascular necrosisPhysica systemLima Corporate S.P.A.K21055404/06/2021OHT6
avascular necrosisBENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.K21061405/24/2022OHT6
avascular necrosisimplaFit® hip stemsImplantcast GmbHK21067808/17/2022OHT6
avascular necrosisCPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLCK21069508/16/2021OHT6
avascular necrosisBone Screws dia. 5,0 mmLima Corporate S.P.A.K21071707/12/2021OHT6
avascular necrosisPersona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.K21082905/18/2021OHT6
avascular necrosisPhantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.K21086906/28/2021OHT6
avascular necrosisRestoration Anatomic ShellHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK21089304/22/2021OHT6
avascular necrosisLINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KGK21089906/21/2021OHT6
avascular necrosisU2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic CorporationK21096104/21/2021OHT6
avascular necrosisGMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.K21100405/13/2021OHT6
avascular necrosisCoCr HeadZimmer GmbHK21104701/10/2023OHT6
avascular necrosisR3 Large Head LinersSmith & Nephew, Inc.K21133001/19/2022OHT6
avascular necrosisTornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationTornier, Inc.K21135911/12/2021OHT6
avascular necrosisBalanced Knee System UniOrtho Development CorporationK21147112/16/2021OHT6
avascular necrosisBiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KGK21156706/03/2022OHT6
avascular necrosisKlassic Knee SystemTotal Joint Orthopedics, Inc.K21160207/23/2021OHT6
avascular necrosisGMK Sphere RevisionMedacta International S.A.K21166407/29/2021OHT6
avascular necrosisELEOS Limb Salvage SystemOnkos SurgicalK21167707/28/2021OHT6
avascular necrosisInsignia Hip StemStryker OrthopaedicsK21170308/16/2021OHT6
avascular necrosisComprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing CorpK21172911/04/2021OHT6
avascular necrosisBencox THR SystemCorentec Co., Ltd.K21186607/14/2021OHT6
avascular necrosisKlassic Knee SystemTotal Joint Orthopedics, Inc.K21187706/22/2022OHT6
avascular necrosisPhysica LMC Knee SystemLimacorporateK21193807/13/2021OHT6
avascular necrosisCatalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.K21199107/28/2021OHT6
avascular necrosisLOSPA TKR SystemCorentec Co., Ltd.K21203412/09/2021OHT6
avascular necrosisCorin MetaFix™ Hip StemCorin U.S.A. LimitedK21206904/07/2022OHT6
avascular necrosisPersona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbHK21212909/28/2021OHT6
avascular necrosisRestoration® Modular Hip SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK21218703/01/2022OHT6
avascular necrosisBiomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K21243102/07/2022OHT6
avascular necrosisComprehensive Humeral Fracture Positioning SleevesBiomet, Inc.K21243512/10/2021OHT6
avascular necrosisG7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.K21251204/28/2022OHT6
avascular necrosisGLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UCK21271009/15/2021OHT6
avascular necrosisBone Cement-Normal ViscosityBiomecanica Industria E Comerciode Produtos Ortopedicos LtdaK21272905/31/2022OHT6
avascular necrosisINHANCE™ Reverse Shoulder SystemDepuy Ireland UCK21273704/21/2022OHT6
avascular necrosisGEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coatingWaldemar Link GmbH & Co. KGK21274209/16/2021OHT6
avascular necrosisPRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.K21280002/25/2022OHT6
avascular necrosisINHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UCK21293306/08/2022OHT6
avascular necrosisPorous PatellaEncore Medical, L.P. Dba Djo SurgicalK21294101/20/2022OHT6
avascular necrosisTomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.K21312410/26/2021OHT6
avascular necrosisRestoration Modular 115mm Conical Distal StemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK21312912/21/2021OHT6
avascular necrosisCatalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.K21334906/23/2022OHT6
avascular necrosisPhysica systemLima Corporate S.P.A.K21338112/17/2021OHT6
avascular necrosisAltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.K21338707/07/2022OHT6
avascular necrosisAdapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.K21358012/03/2021OHT6
avascular necrosisb-ONE MOBIO Total Knee SystemB-One Ortho, Corp.K21367301/21/2022OHT6
avascular necrosisExeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK21370102/01/2022OHT6
avascular necrosisSMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporateK21378505/13/2022OHT6
avascular necrosisEMPOWR Revision KneeEncore Medical L.P.K21379304/01/2022OHT6
avascular necrosisMPO Hip InstrumentsMicroport Orthopedics, Inc.K21381601/05/2022OHT6
avascular necrosisMPO Knee Instruments; MPO PROPHECY Knee InstrumentsMicroport Orthopedics, Inc.K21381701/05/2022OHT6
avascular necrosisTITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)Smith & Nephew, Inc.K21382703/11/2022OHT6
avascular necrosisONVOY Acetabular SystemGlobus Medical, Inc.K21384210/03/2022OHT6
avascular necrosisIdentity Shoulder SystemZimmer, Inc.K21385609/15/2022OHT6
avascular necrosisOptimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLCK22004903/14/2022OHT6
avascular necrosisMg-PSZ Ceramic Femoral HeadTheken CompaniesK22033609/30/2022OHT6
avascular necrosisAcetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK22037603/09/2022OHT6
avascular necrosisTornier Perform Humeral System – StemlessTornier, Inc.K22041809/14/2022OHT6
avascular necrosisBENCOX Mirabo Cup SystemCorentec Co., Ltd.K22046805/18/2022OHT6
avascular necrosisPlatform® Acetabular SystemTotal Joint Orthopedics, Inc.K22048309/23/2022OHT6
avascular necrosisInsignia Hip Stem, Restoration Modular 115mm Conical Distal StemStrykerK22073108/11/2022OHT6
avascular necrosisWorld Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC)Signature Orthopaedics Pty, Ltd.K22073704/11/2022OHT6
avascular necrosisSMR Reverse LinerLima Corporate S.P.A.K22079205/19/2022OHT6
avascular necrosisArthrex DualCompression Hindfoot Fusion Nail Implant SystemArthrex, Inc.K22103112/20/2022OHT6
avascular necrosisActera™ hip systemConformis, Inc.K22110408/04/2022OHT6
avascular necrosisU-Motion II Acetabular System-Extension lineUnited Orthopedic CorporationK22114901/05/2023OHT6
avascular necrosisAdvanced Intramedullary Nail SystemDouble Medical Technology, Inc.K22122112/21/2022OHT6
avascular necrosisPersona Personalized Knee SystemZimmer, Inc.K22147911/17/2022OHT6
avascular necrosisU2 Total Knee System-PF+United Orthopedic CorporationK22170502/28/2023OHT6
avascular necrosisGMK 3D Metal Tibial TrayMedacta International S.A.K22185008/23/2022OHT6
avascular necrosisLINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KGK22206604/14/2023OHT6
avascular necrosisLOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.K22227808/26/2022OHT6
avascular necrosisCatalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.K22231711/10/2022OHT6
avascular necrosisTriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.K22238010/04/2022OHT6
avascular necrosisb-ONER MOBIO Total Knee SystemB-One Ortho, Corp.K22243110/06/2022OHT6
avascular necrosisLatitud™ Hip Replacement SystemMeril Healthcare Pvt. , Ltd.K22243605/09/2023OHT6
avascular necrosisAGILON XO Shoulder SystemImplantcast GmbHK22248209/28/2022OHT6
avascular necrosisZimmer Persona Personalized Knee SystemZimmer, Inc.K22256610/17/2022OHT6
avascular necrosisAltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.K22259206/23/2023OHT6
avascular necrosisJOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.K22265310/28/2022OHT6
avascular necrosisTibial baseplate, Tibial insertUnited Orthopedic CorporationK22270010/06/2022OHT6
avascular necrosisWorld Total Knee SystemSignature Orthopaedics Pty, Ltd.K22306211/04/2022OHT6
avascular necrosisBethaLoc® stem cementless HAImplantcast GmbHK22310306/20/2023OHT6
avascular necrosisINHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UCK22321112/02/2022OHT6
avascular necrosisBENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.K22322302/27/2023OHT6
avascular necrosisGMK Sphere & GMK SpheriKA CementlessMedacta International S.A.K22354801/20/2023OHT6
avascular necrosisComprehensive Segmental Revision System(SRS)Biomet OrthopedicsK22363107/12/2023OHT6
avascular necrosisCatalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.K22365505/09/2023OHT6
avascular necrosisEMPOWR™ blade stemEncore Medical, LLCK22377902/13/2023OHT6
avascular necrosisBENCOX Delta Option HeadsCorentec Co., Ltd.K22382803/16/2023OHT6
avascular necrosisSMR Shoulder SystemLima Corporate S.P.A.K22387602/03/2023OHT6
avascular necrosisKeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.K23012004/19/2024OHT6
avascular necrosisEMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba EnovisK23016904/06/2023OHT6
avascular necrosisPersona™ Personalized Knee SystemZimmer, Inc.K23032103/08/2023OHT6
avascular necrosisEMPOWR Stem Extender, 50mmEncore Medical, L.P Dba EnovisK23044103/17/2023OHT6
avascular necrosisArthrex Univers Apex OptiFit Humeral StemArthrex, Inc.K23051309/26/2023OHT6
avascular necrosisKlassic Knee Revision SystemTotal Joint Othopedics, Inc.K23053705/19/2023OHT6
avascular necrosisEVOLUTION® Hinge Knee SystemMicroport Orthopedics, Inc.K23056309/27/2023OHT6
avascular necrosisINHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UCK23083111/13/2023OHT6
avascular necrosisTriathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK23095206/02/2023OHT6
avascular necrosisSMR Hybrid Glenoid SystemLima Corporate S.P.A.K23109912/21/2023OHT6
avascular necrosisXerxes Hip StemXerxes Arthopedix, LLCK23110906/15/2023OHT6
avascular necrosisACTERA™ hip systemConformis, Inc.K23117805/23/2023OHT6
avascular necrosisRedemption Duo Hindfoot Nail SystemVilex, LLCK23134301/30/2024OHT6
avascular necrosisAGILON® XO Shoulder Replacement SystemImplantcast GmbHK23165702/16/2024OHT6
avascular necrosisMINIMA S SystemLima Corporate S.P.A.K23192507/11/2023OHT6
avascular necrosisEVOLUTION® Cement KeelMicroport Orthopedics, Inc.K23194710/31/2023OHT6
avascular necrosisPNK Total Knee SystemTjc Life Co., Ltd.K23197511/21/2023OHT6
avascular necrosisActinia® hip stemsImplantcast GmbHK23237110/19/2023OHT6
avascular necrosisKlassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.K23241409/08/2023OHT6
avascular necrosisCatalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.K23258309/20/2023OHT6
avascular necrosisAltiVate Reverse® GlenoidEncore Medical L.P.K23348105/29/2024OHT6
avascular necrosisEVOLUTION® Tibial ConesMicroport Orthopedics, Inc.K23350701/18/2024OHT6
avascular necrosis28mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK23372403/11/2024OHT6
avascular necrosisATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee SystemDepuy Ireland UCK23398003/21/2024OHT6
avascular necrosis22.2mm BIOLOX® delta Ceramic V40™ Femoral HeadsHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK23402504/24/2024OHT6
avascular necrosisCatalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K23410504/05/2024OHT6
avascular necrosisEVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Insert; ADVANCED® Revision Product Line Extension; ADVANCE® Total Knee System-Patella; ADVANCE® Tibial Component; Whiteside Condylar II Total Knee Prosthesis; Whiteside ORTHOLOC™; Whiteside ORTHOLOC® M.A. Total Knee System; AXIOM® Total Knee Syst/ACL Retain Tibial Tray/Insert; AXIOM® Total Knee System, A/P Curved Tibial Insert; Second GENERATION KNEE SYSTEM; Whiteside ORTHOLOC® Modular Post. Stab. Knee System; AXIOM® Total Knee System; Thick Tibial Insert; Insall-Burstein II; ORTHOLOC® ADVANTIM® PS LSI TibialMicroport Orthopedics, Inc.K24004304/01/2024OHT6
avascular necrosisEthylene Oxide Sterilization Supplier Change for MPO HipsMicroport OrthopedicsK24004604/18/2024OHT6
avascular necrosisPersona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.K24029904/26/2024OHT6
avascular necrosisEMPOWR Revision Symmetric Knee ConesEncore Medical, L.P. (Dba Enovis)K24032404/26/2024OHT6
avascular necrosisCATALYSTEM Femoral StemsSmith & Nephew, Inc.K24038106/27/2024OHT6
avascular necrosisStryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK24041804/12/2024OHT6
avascular necrosisCeramic Femoral HeadMicroport Orthopedics, Inc.K24045204/12/2024OHT6
avascular necrosisHintermann Series H2 Total Ankle SystemVilex, LLCK24047512/02/2024OHT6
avascular necrosisAnthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K24078310/21/2024OHT6
avascular necrosisEcoFit® short stem cementless cpTiImplantcast GmbHK24083406/03/2024OHT6
avascular necrosisIdentity Shoulder SystemZimmer, Inc.K24087606/12/2024OHT6
avascular necrosisThe Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLCK24093806/27/2024OHT6
avascular necrosisATTUNE™ Revision Knee System;  DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;Depuy Ireland UCK24100007/11/2024OHT6
avascular necrosisACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.K24126012/06/2024OHT6
avascular necrosisIcona Hip StemCorin U.S.A. LimitedK24147210/03/2024OHT6
avascular necrosisceramys™ femoral head systemEncore Medical L.P.K24148302/07/2025OHT6
avascular necrosisBlueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)K24149110/10/2024OHT6
avascular necrosisTornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)K24160909/10/2024OHT6
avascular necrosisMobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KGK24163611/08/2024OHT6
avascular necrosisLogical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.K24169008/01/2024OHT6
avascular necrosisInSet Total Shoulder SystemShoulder Innovations, Inc.K24181702/11/2025OHT6
avascular necrosisTornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)K24187812/06/2024OHT6
avascular necrosisAGILON® XO Shoulder Replacement SystemImplantcast GmbHK24194403/10/2025OHT6
avascular necrosisInitia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.K24204504/10/2025OHT6
avascular necrosisEXULT Knee Replacement SystemCorentec Co., Ltd.K24204608/01/2024OHT6
avascular necrosisResolve Modular Revision Hip StemUnited Orthopedic CorporationK24231505/01/2025OHT6
avascular necrosisEXULT Knee Replacement SystemCorentec Co., Ltd.K24240109/12/2024OHT6
avascular necrosisNextStep Arthropedix Total Knee SystemNextstep ArthropedixK24241005/08/2025OHT6
avascular necrosisPersona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.K24254311/22/2024OHT6
avascular necrosisJOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.K24271110/30/2024OHT6
avascular necrosisTrinity EVO Acetabular ShellCorin U.S.A. LimitedK24274406/05/2025OHT6
avascular necrosisTriathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK24283112/04/2024OHT6
avascular necrosisLongboard Revision Hip StemSignature Orthopaedics Pty, Ltd.K24302108/07/2025OHT6
avascular necrosisWorld LinerSignature Orthopaedics Pty, Ltd.K24316211/25/2024OHT6
avascular necrosisPersona the Personalized Knee SystemZimmer, Inc.K24324710/29/2024OHT6
avascular necrosisINHANCE INTACT™Depuy Ireland UCK24324812/23/2024OHT6
avascular necrosisZimmer® Persona® Personalized Knee SystemZimmer BiometK24329312/20/2024OHT6
avascular necrosisBIOCERAM AZUL® HEADKyocera CorporationK24344412/05/2024OHT6
avascular necrosisONVOY™ Acetabular SystemGlobus Medical, Inc.K24345606/06/2025OHT6
avascular necrosisEvolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.K24357402/18/2025OHT6
avascular necrosisPhysica Porous Femoral ComponentsLima Corporate S.P.A.K24361512/18/2024OHT6
avascular necrosisU2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic CorporationK24365607/31/2025OHT6
avascular necrosisPersona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.K24372403/06/2025OHT6
avascular necrosisStryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK24378402/06/2025OHT6
avascular necrosisBiolox® Delta Revision headsLimacorporateK24380903/04/2025OHT6
avascular necrosisMobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KGK24392705/16/2025OHT6
avascular necrosisKlassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.K24399103/24/2025OHT6
avascular necrosisMedalOne Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K24403902/28/2025OHT6
avascular necrosisAllure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK25037511/05/2025OHT6
avascular necrosisNEXUS® Hip StemMicroport Orthopedics, Inc.K25044405/15/2025OHT6
avascular necrosisCATALYSTEM Femoral StemsSmith & Nephew, Inc.K25057103/28/2025OHT6
avascular necrosisSuccession™ AFN SystemOrtho Solutions UK , Ltd.K25062208/07/2025OHT6
avascular necrosisDynaNail TTC Fusion SystemMedShape, Inc.K25062809/12/2025OHT6
avascular necrosisIdentity Shoulder SystemZimmer, Inc.K25084807/02/2025OHT6
avascular necrosisEXULT Knee Replacement SystemCorentec Co., Ltd.K25088904/17/2025OHT6
avascular necrosisPhysica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.K25098005/22/2025OHT6
avascular necrosisIdentity Revision Humeral StemsZimmer, Inc.K25109808/11/2025OHT6
avascular necrosisAltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid SystemEncore Medical L.P.K25118405/16/2025OHT6
avascular necrosisEMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.K25124107/02/2025OHT6
avascular necrosisTaperloc® Complete Hip StemBiomet, Inc.K25127005/19/2026OHT6
avascular necrosisTornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K25168610/30/2025OHT6
avascular necrosisEMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.K25177607/08/2025OHT6
avascular necrosisEMPOWR Acetabular® Liner ExtensionEncore Medical L.P.K25183311/12/2025OHT6
avascular necrosisPersona Partial KneeZimmer BiometK25183408/15/2025OHT6
avascular necrosisZimmer® Persona® Personalized Knee SystemZimmer, Inc.K25184005/28/2026OHT6
avascular necrosisPhantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.K25185007/14/2025OHT6
avascular necrosisTriathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK25204410/24/2025OHT6
avascular necrosisVelora Acetabular SystemRestor3D, Inc.K25206712/05/2025OHT6
avascular necrosisAltiVate Reverse® GlenoidEncore Medical L.P.K25214108/05/2025OHT6
avascular necrosisSMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.K25235201/22/2026OHT6
avascular necrosisimplaFit® short stemsImplantcast GmbHK25240103/12/2026OHT6
avascular necrosisCatalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K25241811/06/2025OHT6
avascular necrosisEPORE® XO cup systemImplantcast GmbHK25245104/24/2026OHT6
avascular necrosisAltiVate Reverse® ADLC GlenosphereEncore Medical L.P.K25256701/15/2026OHT6
avascular necrosisG7® Revision Acetabular SystemZimmer, Inc.K25262302/04/2026OHT6
avascular necrosisStem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic CorporationK25272509/25/2025OHT6
avascular necrosisTornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.K25278801/08/2026OHT6
avascular necrosisELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc.K25292010/15/2025OHT6
avascular necrosisEMPOWR KneeEncore Medical L.P.K25297412/19/2025OHT6
avascular necrosisELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc.K25306606/08/2026OHT6
avascular necrosisLibertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.K25317101/15/2026OHT6
avascular necrosisPersona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K25318903/09/2026OHT6
avascular necrosisATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UCK25319711/19/2025OHT6
avascular necrosisActive-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K25323912/23/2025OHT6
avascular necrosisGMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K25332802/26/2026OHT6
avascular necrosisPhantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.K25359103/05/2026OHT6
avascular necrosisTriathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK25363702/18/2026OHT6
avascular necrosisimplantcast Packaging System UpdateImplantcast GmbHK26003703/30/2026OHT6
avascular necrosisTornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K26010206/12/2026OHT6
avascular necrosisAvenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K26018204/27/2026OHT6
avascular necrosisNovoKnee (SteriKnee)NovoSourceK26103204/27/2026OHT6
avascular necrosisPatient Specific Talus SpacerParagon 28, Inc.H20000102/17/2021OHT6
avascular necrosisrestor3d Total Talus ReplacementRestor3D, Inc.H23000311/17/2023OHT6
avascular necrosis4WEB Medical Talar Replacement DeviceStrykerH24000112/27/2024OHT6
avascular necrosisOxford™ Cementless Partial Knee SystemBiomet Manufacturing CorpP010014/S10511/22/2024OHT6
avascular necrosisCERAMAX CERAMIC HIP SYSTEMDePuy Orthopaedics, Inc.P07002612/23/2010OHT6
avascular necrosisAUGMENT BONE GRAFTBiomimetic Therapeutics, LLCP10000609/01/2015OHT6
avascular necrosis; avascular necrosis of the femoral headVESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERSMedacta International S.A.K09226503/12/2010OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY CORAIL HIP SYSTEM, REVISION STEMDePuy Orthopaedics, Inc.K09373603/10/2011OHT6
avascular necrosis; avascular necrosis of the femoral headMEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA SMedacta International S.A.K09394401/21/2010OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY UNIVERSAL GRIPTION TF CONESDePuy Orthopaedics, Inc.K10039109/29/2010OHT6
avascular necrosis; avascular necrosis of the femoral headCONSENSUS CS2 PLUS ACETABULAR INSERTConsensus Orthopedics, Inc.K10093310/06/2010OHT6
avascular necrosis; avascular necrosis of the femoral headCONSENSUS TAPERSET HIP SYSTEMConsensus Orthopedics, Inc.K10239912/02/2010OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY PINNACLE ALTRX ACETABULAR LINERSDePuy Orthopaedics, Inc.K10242310/29/2010OHT6
avascular necrosis; avascular necrosis of the femoral headPREVISION HIP SYSTEM WITH RECON RINGAesculap Implant Systems, LLCK10242412/09/2010OHT6
avascular necrosis; avascular necrosis of the femoral headMEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECKMedacta International S.A.K10318912/20/2010OHT6
avascular necrosis; avascular necrosis of the femoral headVERSAFITCUP CC TRIOMedacta InternationalK10335202/11/2011OHT6
avascular necrosis; avascular necrosis of the femoral headESCALADE ACETABULAR CUP SYSTEMOrtho DevelopmentK10338403/16/2011OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT ACETABULAR SYSTEMMedacta InternationalK10372103/21/2011OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARCUP DUAL MOBILITY SYSTEMSmith & Nephew, Inc.K11013510/14/2011OHT6
avascular necrosis; avascular necrosis of the femoral headCONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEADConsensus Orthopedics, Inc.K11054204/01/2011OHT6
avascular necrosis; avascular necrosis of the femoral headHELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICONTgm MedicalK11147209/06/2011OHT6
avascular necrosis; avascular necrosis of the femoral headCORIN OPTIMOM MODULAR HEADCorin USAK11191108/04/2011OHT6
avascular necrosis; avascular necrosis of the femoral headORTHO DEVLOPMENT CERAMIC FEMORAL HEADOrtho DevelopmentK11193609/21/2011OHT6
avascular necrosis; avascular necrosis of the femoral headMECTACER BIOLOX(R) DELTA FEMORAL HEADSMedacta InternationalK11211510/07/2011OHT6
avascular necrosis; avascular necrosis of the femoral headSL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATINGSmith & Nephew, Inc.K12021107/19/2012OHT6
avascular necrosis; avascular necrosis of the femoral headVERSAFITCUP CC TRIO-ADDITIONAL LINERSMedacta InternationalK12053104/18/2012OHT6
avascular necrosis; avascular necrosis of the femoral headUNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K12059510/12/2012OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY M-SPEC 36MM FEMORAL HEADSDepuy OrthopaedicsK12059904/30/2013OHT6
avascular necrosis; avascular necrosis of the femoral headAMISTEM AND QUADRA - LINE EXTENSIONMedacta InternationalK12101106/08/2012OHT6
avascular necrosis; avascular necrosis of the femoral headIOI TOTAL HIPIconacy Orthopedic Implants, LLCK12103409/04/2012OHT6
avascular necrosis; avascular necrosis of the femoral headTAPER SET HIP SYSTEM RDP STEMConsensus Orthopedics, Inc.K12126305/22/2012OHT6
avascular necrosis; avascular necrosis of the femoral headZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERTTgm Medical, Inc.K12163610/24/2012OHT6
avascular necrosis; avascular necrosis of the femoral headTAPERSET HIP SMALL STEMSConsensus Orthopedics, Inc.K12193509/10/2012OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARCUP DUAL MOBILITY SYSTEMSmith & Nephew, Inc.K12224408/23/2012OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT EXTENSIONMedacta InternationalK12264109/28/2012OHT6
avascular necrosis; avascular necrosis of the femoral headPLASMAFIT ACETABULAR CUP AND VITELENE INSERTAesculap Implant System, Inc.K12278310/30/2013OHT6
avascular necrosis; avascular necrosis of the femoral headVERSAFITCUP CC TRIO EXTENSIONMedacta InternationalK12291110/19/2012OHT6
avascular necrosis; avascular necrosis of the femoral headAVENIR MULLER STEMZimmer GmbHK12339203/04/2013OHT6
avascular necrosis; avascular necrosis of the femoral headINTRABLOCK BIOBALL HIP SYSTEM (IBS)Merete Medical GmbHK12361905/24/2013OHT6
avascular necrosis; avascular necrosis of the femoral headPARAGON HIP SYSTEMGlobal Manufacturing TechnologyK12378203/14/2013OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWSDepuy OrthopaedicsK12392403/01/2013OHT6
avascular necrosis; avascular necrosis of the femoral headVITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERTConsensus Orthopedics, Inc.K13065212/17/2013OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HASmith & Nephew, Inc.K13072810/10/2013OHT6
avascular necrosis; avascular necrosis of the femoral headICONACY I-HIP SYSTEMIconacy Orthopedic Implants, LLCK13127908/09/2013OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT DM LINER CONVERTERMedacta InternationalK13145810/01/2013OHT6
avascular necrosis; avascular necrosis of the femoral headMECTACER BIOLOX OPTION HEADSMedacta InternationalK13151811/04/2013OHT6
avascular necrosis; avascular necrosis of the femoral headAVENIR CEMENTED HIP STEMZimmer GmbHK13188408/22/2013OHT6
avascular necrosis; avascular necrosis of the femoral headSMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALSSmith & Nephew, Inc.K13243510/22/2013OHT6
avascular necrosis; avascular necrosis of the femoral headI-HIP TOTAL HIP SYSTEMIconacy Orthopedic Implants, LLCK13257203/28/2014OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT EXTENSIONMedacta InternationalK13287901/22/2014OHT6
avascular necrosis; avascular necrosis of the femoral headDEPUY PINNACLE ALTRX ACETABULAR LINERSDePuy Orthopaedics, Inc.K13295903/10/2014OHT6
avascular necrosis; avascular necrosis of the femoral headICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEMIconacy Orthopedic Implants, LLCK13322801/17/2014OHT6
avascular necrosis; avascular necrosis of the femoral headREMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CESignature Orthopaedics Pty LimitedK13337007/22/2014OHT6
avascular necrosis; avascular necrosis of the femoral headEXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEMExcera Orthopedics, Inc.K14054701/22/2015OHT6
avascular necrosis; avascular necrosis of the femoral headEXCIA TOTAL HIP SYSTEMAesculap Implant Systems, LLCK14091507/21/2014OHT6
avascular necrosis; avascular necrosis of the femoral headCS2 MULTI-HOLE ACETABULAR SHELLConsensus Orthopedics, Inc.K14104305/19/2014OHT6
avascular necrosis; avascular necrosis of the femoral headBIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARDMerete Medical GmbHK14137711/21/2014OHT6
avascular necrosis; avascular necrosis of the femoral headEvolve UniPolar HeadSignature Orthopaedics Pty, Ltd.K14318403/17/2015OHT6
avascular necrosis; avascular necrosis of the femoral headMpact Double Mobility SystemMedacta InternationalK14345303/02/2015OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.K14373904/20/2015OHT6
avascular necrosis; avascular necrosis of the femoral headExcia Total Hip SystemAesculap Implant Systems, LLCK15006202/09/2015OHT6
avascular necrosis; avascular necrosis of the femoral headTGM Biolox delta Ceramic HeadsTgm Medical, Inc.K15057609/09/2015OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.K15086209/25/2015OHT6
avascular necrosis; avascular necrosis of the femoral headICONACY(TM) I-Hip (TM)Iconacy Orthopedic Implants, LLCK15130702/26/2016OHT6
avascular necrosis; avascular necrosis of the femoral headMasterLoc StemMedacta InternationalK15153110/30/2015OHT6
avascular necrosis; avascular necrosis of the femoral headFitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.K15305706/23/2016OHT6
avascular necrosis; avascular necrosis of the femoral headLogical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd.K15313106/03/2016OHT6
avascular necrosis; avascular necrosis of the femoral headICONACY(TM) I-Hip(TM)Iconacy Orthopedic Implants, LLCK16026604/08/2016OHT6
avascular necrosis; avascular necrosis of the femoral headMasterLoc StemMedacta InternationalK16028905/20/2016OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Actis DuoFix Hip ProsthesisDepuy(Ireland)K16090707/19/2016OHT6
avascular necrosis; avascular necrosis of the femoral headEscalade Legend Acetabular ShellOrtho Development CorporationK16108005/17/2016OHT6
avascular necrosis; avascular necrosis of the femoral headOrigin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.K16115507/19/2016OHT6
avascular necrosis; avascular necrosis of the femoral headAMIStem-H Proximal CoatingMedacta International S.A.K16163503/31/2017OHT6
avascular necrosis; avascular necrosis of the femoral headU2 Femoral HeadUnited Orthopedic CorporationK16295707/17/2017OHT6
avascular necrosis; avascular necrosis of the femoral head40-42mm BiPolar Head and 22mm Femoral HeadSignature Orthopaedics Pty, Ltd.K16308101/29/2018OHT6
avascular necrosis; avascular necrosis of the femoral headSummit Hip SystemDePuy Orthopaedics, Inc.K17033904/26/2018OHT6
avascular necrosis; avascular necrosis of the femoral headM-Vizion Femoral Revision SystemMedacta International S.A.K17069011/29/2017OHT6
avascular necrosis; avascular necrosis of the femoral headMiniMAXMedacta International S.A.K17084508/08/2017OHT6
avascular necrosis; avascular necrosis of the femoral headMpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.K17196603/27/2018OHT6
avascular necrosis; avascular necrosis of the femoral headMasterLoc Stem: Lateralized PlusMedacta International S.A.K17326712/07/2017OHT6
avascular necrosis; avascular necrosis of the femoral headb-ONE® Total Hip SystemB-One Ortho, Corp.K17338008/30/2018OHT6
avascular necrosis; avascular necrosis of the femoral headAMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.K17379403/14/2018OHT6
avascular necrosis; avascular necrosis of the femoral headMicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)K17389809/20/2018OHT6
avascular necrosis; avascular necrosis of the femoral headLegend Acetabular LinersOrtho Development CorporationK17395105/30/2018OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Corail AMT Hip ProsthesisDepuy France S.A.S.K17396009/21/2018OHT6
avascular necrosis; avascular necrosis of the femoral headZimmer Biomet Ceramic HeadsZimmer, Inc.K18117104/02/2019OHT6
avascular necrosis; avascular necrosis of the femoral headQuadra PMedacta International S.A.K18125410/22/2018OHT6
avascular necrosis; avascular necrosis of the femoral headCemented TSI Hip StemSignature Orthopaedics Pty, Ltd.K18134002/11/2019OHT6
avascular necrosis; avascular necrosis of the femoral headREDAPT Porous Acetabular ShellSmith & Nephew, Inc.K18136609/24/2018OHT6
avascular necrosis; avascular necrosis of the femoral headSMS Femoral StemMedacta International S.A.K18169311/28/2018OHT6
avascular necrosis; avascular necrosis of the femoral headZimmer Biomet Select Ceramic HeadsZimmer, Inc.K18176112/26/2018OHT6
avascular necrosis; avascular necrosis of the femoral headAvenir Complete Hip SystemZimmer, Inc.K18204812/07/2018OHT6
avascular necrosis; avascular necrosis of the femoral headZimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.K18267805/31/2019OHT6
avascular necrosis; avascular necrosis of the femoral headJuveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsB-One Ortho, Corp.K18270502/14/2019OHT6
avascular necrosis; avascular necrosis of the femoral headConformity StemUnited Orthopedic CorporationK18331208/08/2019OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT ExtensionMedacta International S.A.K18358203/21/2019OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Corail AMT Hip ProsthesisDepuy(Ireland)K19034411/01/2019OHT6
avascular necrosis; avascular necrosis of the femoral headSignature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.K19070408/28/2019OHT6
avascular necrosis; avascular necrosis of the femoral headOR3O Dual Mobility SystemSmith & Nephew, Inc.K19100210/31/2019OHT6
avascular necrosis; avascular necrosis of the femoral headConformity stem, cementedUnited Orthopedic CorporationK19105601/03/2020OHT6
avascular necrosis; avascular necrosis of the femoral headMasterLoc ExtensionMedacta International S.A.K19114505/30/2019OHT6
avascular necrosis; avascular necrosis of the femoral headOrigin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.K19170808/14/2020OHT6
avascular necrosis; avascular necrosis of the femoral headM-Vizion Femoral Revision System ExtensionMedacta International S.A.K19181604/29/2020OHT6
avascular necrosis; avascular necrosis of the femoral headKeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.K19182605/14/2020OHT6
avascular necrosis; avascular necrosis of the femoral headCemented TSI Hip StemSignature Orthopaedics Pty, Ltd.K19202406/19/2020OHT6
avascular necrosis; avascular necrosis of the femoral headAMIStem-P Short NeckMedacta International S.A.K19212611/22/2019OHT6
avascular necrosis; avascular necrosis of the femoral headAvenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.K19218912/18/2019OHT6
avascular necrosis; avascular necrosis of the femoral headMiniMAXMedacta International S.A.K19235209/27/2019OHT6
avascular necrosis; avascular necrosis of the femoral headQuadra-PMedacta International S.A.K19282701/06/2020OHT6
avascular necrosis; avascular necrosis of the femoral headSpartan Hip StemSignature Orthopaedics Pty, Ltd.K19288308/05/2020OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.K19294611/26/2019OHT6
avascular necrosis; avascular necrosis of the femoral headAvenir Muller Stem, Avenir Cemented Hip StemZimmer GmbHK19303012/06/2019OHT6
avascular necrosis; avascular necrosis of the femoral headSummit DuoFix HA CoatingDePuy Orthopaedics, Inc.K19339802/04/2020OHT6
avascular necrosis; avascular necrosis of the femoral headAMIStem-CMedacta International S.A.K19343301/09/2020OHT6
avascular necrosis; avascular necrosis of the femoral headMPACT ExtensionMedacta International S.A.K20039104/28/2021OHT6
avascular necrosis; avascular necrosis of the femoral headWorld Hip Stem, World Cup, World LinerSignature Orthopaedics Pty, Ltd.K20127809/21/2020OHT6
avascular necrosis; avascular necrosis of the femoral headM-Vizion Femoral Revision System ExtensionMedacta International S.A.K20147101/11/2021OHT6
avascular necrosis; avascular necrosis of the femoral headSMS Cementless StemMedacta International S.A.K20167309/18/2020OHT6
avascular necrosis; avascular necrosis of the femoral headCemented Origin Hip StemSignature Orthopaedics Pty, Ltd.K20195107/31/2020OHT6
avascular necrosis; avascular necrosis of the femoral headACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.K20247210/21/2020OHT6
avascular necrosis; avascular necrosis of the femoral headMpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.K20256812/20/2021OHT6
avascular necrosis; avascular necrosis of the femoral headQuadra-PMedacta International S.A.K20273012/28/2020OHT6
avascular necrosis; avascular necrosis of the femoral headKOSMO Femoral StemB-One Ortho, Corp.K20276804/01/2021OHT6
avascular necrosis; avascular necrosis of the femoral headSMS Cementless StemMedacta International S.A.K20304112/02/2020OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.K20316711/19/2020OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARSTEM Cemented Femoral StemSmith & Nephew, Inc.K20317507/22/2021OHT6
avascular necrosis; avascular necrosis of the femoral headMectaplug PE IIMedacta International S.A.K21006204/08/2021OHT6
avascular necrosis; avascular necrosis of the femoral headMpres Neck Preserving StemMedacta International S.A.K21026309/22/2021OHT6
avascular necrosis; avascular necrosis of the femoral headActis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UCK21058105/20/2021OHT6
avascular necrosis; avascular necrosis of the femoral headEncore Hip StemSignature Orthopaedics Pty, Ltd.K21150509/24/2021OHT6
avascular necrosis; avascular necrosis of the femoral headPOLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.K21154807/19/2021OHT6
avascular necrosis; avascular necrosis of the femoral headEMPHASYS Femoral StemsDepuy Ireland UCK21165708/05/2021OHT6
avascular necrosis; avascular necrosis of the femoral headSignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.K21174201/07/2022OHT6
avascular necrosis; avascular necrosis of the femoral headDM Converter - TiN coatedMedacta International S.A.K21189107/22/2022OHT6
avascular necrosis; avascular necrosis of the femoral headM-Vizion MonoblocMedacta International S.A.K21232705/24/2022OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.K21383901/06/2022OHT6
avascular necrosis; avascular necrosis of the femoral headC-Stem AMT LE ProsthesisDepuy Ireland UCK22021607/22/2022OHT6
avascular necrosis; avascular necrosis of the femoral headAmis K LongMedacta International S.A.K22040504/12/2022OHT6
avascular necrosis; avascular necrosis of the femoral headSignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.K22049501/13/2023OHT6
avascular necrosis; avascular necrosis of the femoral headOR3O Dual Mobility SystemSmith & Nephew, Inc.K22095908/18/2022OHT6
avascular necrosis; avascular necrosis of the femoral headEMPHASYS Acetabular SystemDepuy Ireland UCK22163609/06/2022OHT6
avascular necrosis; avascular necrosis of the femoral headUnited U2 femoral head, 22mm delta ceramic headUnited Orthopedic CorporationK22167511/04/2022OHT6
avascular necrosis; avascular necrosis of the femoral headARTICUL/EZE Ceramic HeadsDepuy Ireland UCK22229601/06/2023OHT6
avascular necrosis; avascular necrosis of the femoral headMpact ExtensionMedacta International S.A.K23001109/20/2023OHT6
avascular necrosis; avascular necrosis of the femoral headCORAIL Cemented Femoral StemDepuy Ireland UCK23152612/19/2023OHT6
avascular necrosis; avascular necrosis of the femoral headDePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalDepuy Ireland UCK23187301/19/2024OHT6
avascular necrosis; avascular necrosis of the femoral headOR3O Dual Mobility LinersSmith & Nephew, Inc.K23266710/27/2023OHT6
avascular necrosis; avascular necrosis of the femoral headEMPHASYS Femoral StemsDepuy Ireland UCK23323310/11/2023OHT6
avascular necrosis; avascular necrosis of the femoral headZ1 Hip SystemOrchard Medical DevelopmentK23347602/08/2024OHT6
avascular necrosis; avascular necrosis of the femoral headb-ONE® Total Hip SystemB-One Ortho, Corp.K24052811/15/2024OHT6
avascular necrosis; avascular necrosis of the femoral headZ1 Cemented Hip SystemOrchard Medical Development, LLCK24124108/27/2024OHT6
avascular necrosis; avascular necrosis of the femoral headMpact Constrained LinerMedacta International S.A.K24146107/31/2025OHT6
avascular necrosis; avascular necrosis of the femoral headVersacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.K24176703/06/2025OHT6
avascular necrosis; avascular necrosis of the femoral headEMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UCK24208410/07/2024OHT6
avascular necrosis; avascular necrosis of the femoral headConformity Stem Extension LineUnited Orthopedic CorporationK24224908/30/2024OHT6
avascular necrosis; avascular necrosis of the femoral headOR3O Dual Mobility SystemSmith & Nephew, Inc.K24237510/07/2024OHT6
avascular necrosis; avascular necrosis of the femoral headLegend® Acetabular ShellOrtho Development Corp.K24283310/11/2024OHT6
avascular necrosis; avascular necrosis of the femoral headOrigin™ TT StemSignature Orthopaedics Pty, Ltd.K24302903/11/2025OHT6
avascular necrosis; avascular necrosis of the femoral headOrigin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.K24304305/02/2025OHT6
avascular necrosis; avascular necrosis of the femoral headConformity Stem Extension Line, #0United Orthopedic CorporationK24346601/06/2025OHT6
avascular necrosis; avascular necrosis of the femoral headEMPHASYS Acetabular SystemDepuy Ireland UCK24397701/22/2025OHT6
avascular necrosis; avascular necrosis of the femoral headCoated hip implantsMedacta International S.A.K25045009/19/2025OHT6
avascular necrosis; avascular necrosis of the femoral headZimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer BiometK25083404/18/2025OHT6
avascular necrosis; avascular necrosis of the femoral headMpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.K25104301/28/2026OHT6
avascular necrosis; avascular necrosis of the femoral headMfinity Femoral SystemMedacta International S.A.K25116606/13/2025OHT6
avascular necrosis; avascular necrosis of the femoral headZ1 Hip SystemZimmer, Inc.K25190607/18/2025OHT6
avascular necrosis; avascular necrosis of the femoral headEvolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K25282403/12/2026OHT6
avascular necrosis; avascular necrosis of the femoral headTaperSet™ Hip SystemShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK25284611/20/2025OHT6
avascular necrosis; avascular necrosis of the femoral headb-ONE® Bipolar HeadB-One Ortho, Corp.K25335704/13/2026OHT6
avascular necrosis; avascular necrosis of the femoral head; Legg-Calve-Perthes disease; Perthes disease; poliomyelitisSmith & Nephew Plates and ScrewsSmith & Nephew, Inc.K21083706/29/2021OHT6
avascular necrosis; avascular necrosis of the femoral head; idiopathic avascular necrosisENCOMPASS 10/12 HIP STEMOrtho Development Corp.K13269706/20/2014OHT6
avascular necrosis; avascular necrosis of the femoral head; idiopathic avascular necrosisAlpine Cemented Hip SystemOrtho Development CorporationK15321602/18/2016OHT6
avascular necrosis; avascular necrosis of the femoral head; idiopathic avascular necrosisEntrada™ hip stemOrtho Development CorporationK17124908/24/2017OHT6
avascular necrosis; avascular necrosis of the femoral head; idiopathic avascular necrosisTrivicta™ Hip StemOrtho Development Corp.K23375803/08/2024OHT6
avascular necrosis; avascular necrosis of the femoral head; idiopathic avascular necrosisTrivicta® Hip StemOrtho Development Corp.K25105205/22/2025OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisMSA HIP SYSTEMGlobal Manufacturing TechnologyK10217203/01/2011OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisMETHA HIP SYSTEMAesculap Implant Systems, LLCK11268203/19/2012OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisMSA HIP SYSTEMGlobal Manufacturing TechnologyK11310712/15/2011OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisBIOLOX DELTA CERAMIC FEMORAL HEADSZimmer GmbHK13089905/01/2013OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisZimmer M/L Taper Hip ProsthesisZimmer, Inc.K16183010/26/2016OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisCoreHip® SystemAesculap Implants Systems, LLCK17223503/28/2018OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisCPT Hip SystemZimmer, Inc.K19173503/20/2020OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisBIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbHK19241610/01/2019OHT6
avascular necrosis; avascular necrosis of the femoral head; slipped capital femoral epiphysisZimmer M/L Taper Hip ProsthesisZimmer, Inc.K19266002/28/2020OHT6
avascular necrosis; chondrosarcomaUSTAR II SystemUnited Orthopedic CorporationK19010009/23/2019OHT6
avascular necrosis; chondrosarcomaStem Extension Line (USTAR II System)United Orthopedic CorporationK25230308/22/2025OHT6
avascular necrosis; hemophiliaTEMA Elbow SystemLima Corporate S.P.A.K18136202/16/2019OHT6
avascular necrosis; hemophiliaTEMA Elbow system - Line extensionLima Corporate S.P.A.K22280710/26/2022OHT6
avascular necrosis; idiopathic avascular necrosisOVATION 10/12 HIP STEMOrtho Development Corp.K13102210/16/2013OHT6
avascular necrosis; idiopathic avascular necrosisALPINE HIP STEM; ALPINE HA HIP STEMOrtho DevelopmentK14100107/30/2014OHT6
avascular necrosis; idiopathic avascular necrosisStryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK23349812/21/2023OHT6
avascular necrosis; osteomyelitisSLR-PLUS STANDARD AND LATERAL FEMORAL STEMSSmith & Nephew, Inc.K09399104/15/2010OHT6
avascular necrosis; osteomyelitisSL-PLUS MIA FEMORAL STEMS WITH TI/HA COATINGSmith & Nephew, Inc.K12229608/28/2012OHT6
avascular necrosis; osteomyelitisSMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.K12359806/28/2013OHT6
avascular necrosis; osteomyelitisSL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc.K14309603/24/2015OHT6
avascular necrosis; osteonecrosisITOTAL CR KNEE REPLACEMENT SYSTEMConformis, Inc.K09405009/16/2010OHT6
avascular necrosis; osteonecrosisAPEX K1 HIP STEMOmni Life Science, Inc.K11094706/16/2011OHT6
avascular necrosis; osteonecrosisAPEX ARC HIP STEMOmni Life Science, Inc.K11119306/27/2011OHT6
avascular necrosis; osteonecrosisAPEX ARC HIP STEMOmni Life Science, Inc.K11324201/05/2012OHT6
avascular necrosis; osteonecrosisSmith & Nephew Hip SystemsSmith & Nephew, Inc.K21117607/01/2022OHT6
avascular necrosis; osteonecrosisTheRay Collared and Collarless Femoral StemNextstep ArthropedixK24187509/13/2024OHT6
avascular necrosis; osteonecrosisEquinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K25071312/01/2025OHT6
avascular necrosis; osteonecrosisStryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)K25098907/25/2025OHT6
avascular necrosis; sickle cell anemiaBone Cement Genta, Bone Cement HV, Bone Cement LVTecres S.P.A.K21116301/09/2023OHT6
avascular necrosis; slipped capital femoral epiphysisMULTIFIT TOTAL HIP SYSTEMOtis Biotech Co., Ltd.K10147201/05/2011OHT6
avascular necrosis; slipped capital femoral epiphysisPinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.K19291911/26/2019OHT6
bilirubin encephalopathy; KernicterusARCHITECT TOTAL BILIRUBINAbbott LaboratoriesK12198502/01/2013OHT7
bilirubin encephalopathy; kernicterusTotal BilirubinAbbott LaboratoriesK15051004/02/2015OHT7
bilirubin encephalopathy; kernicterusADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc.K17006503/09/2017OHT7
bilirubin encephalopathy; kernicterusAtellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K25199802/27/2026OHT7
biotinidase deficiencyNEONATAL BIOTINIDASE KIT, MODEL 3018Perkinelmer, Inc.K09012303/05/2010OHT7
bowenoid papulosis; erythroplasia of QueyratLIGHTSCALPEL LS-4020Lightscalpel, Inc.K21366902/15/2023OHT4
bowenoid papulosis; erythroplasia of QueyratThe Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and AccessoriesLumenis Be, Ltd.K22046705/18/2022OHT4
bowenoid papulosis; erythroplasia of QueyratULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesLumenis Be, Ltd.K23330112/01/2023OHT4
bullous pemphigoidEUROIMMUN Anti-BP230-CF ELISA (IgG)Euroimmun Us, Inc.K19311509/17/2020OHT7
carcinoma of the larynxVECTRA PLUS LASER SYSTEM AND ACCESSORIESXintec CorporationK08223002/03/2010OHT4
carcinoma of the larynxQUANTA DIODE LASER SYSTEMQuanta System SpaK10055807/22/2010OHT4
carcinoma of the larynxDOCTOR SURGERY DIODE LASERS FAMILYLambda S.P.A.K10203609/28/2010OHT4
carcinoma of the larynxEVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASERBiolitec, Inc.K11201301/13/2012OHT4
carcinoma of the larynxEVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)Biolitec Medical Devices, Inc.K12023104/24/2012OHT4
carcinoma of the larynxRapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L.K24054310/24/2024OHT4
causalgia; complex regional pain syndrome; reflex sympathetic dystrophyAxium Neurostimulator SystemABBOTT MEDICALP15000402/11/2016OHT5
cavernous hemangiomaGuardian 1000Quanta System SpaK15162910/27/2015OHT4
cavernous hemangioma; erythroplasia of QueyratBLUESHINE'S GOLD SERIESBlueshine SrlK11037502/23/2012OHT4
central retinal vein occlusionMODEL VISULAS 532S LASER WITH THE VITE OPTIONCarl Zeiss Meditec, AGK10003503/17/2010OHT4
central retinal vein occlusion; central serous chorioretinopathyLumenis Smart532 Laser SystemLumenis, Inc.K15110910/30/2015OHT4
cervical dystonia; torticollisMedtronic DBS Therapy for DystoniaMedtronic, Inc.P960009/S48211/22/2025OHT5
chikungunya; dengue disease; Leptospira spp. (Leptospirosis); Plasmodium spp. (malaria)FilmArray Global Fever PanelBiofire Defense, LLCDEN20004311/20/2020OHT7
chikungunya; dengue disease; Leptospira spp. (leptospirosis); Plasmodium spp. (malaria)BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelBiofire Defense, LLCK22087010/20/2022OHT7
chikungunya; dengue disease; Leptospira spp. (leptospirosis); Plasmodium spp. (malaria)BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)K24346312/05/2024OHT7
choanal atresiaLAURIMED POLYPVAC MICRODEBRIDERLaurimed, LLCK13313312/23/2013OHT1
choleraxTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.K18302311/30/2018OHT7
choleraxTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.K18303011/30/2018OHT7
choleraxTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc.K19116011/04/2019OHT7
cholera; Entamoeba histolytica (Amoebiasis due to Entamoeba histolytica); Shigella (Shigellosis)XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)Luminex Molecular Diagnostics, Inc.K14037709/16/2014OHT7
cholera; Entamoeba histolytica (Amoebiasis due to Entamoeba histolytica); Shigella (Shigellosis)XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)Luminex Molecular Diagnostics, Inc.K14064710/24/2014OHT7
choroidal melanoma; retinoblastoma; retinopathy of prematurityIridex 810 LaserIridex CorporationK20276010/21/2020OHT1
choroidal melanoma; retinoblastoma; retinopathy of prematurityIridex 810 LaserIridex CorporationK21359203/23/2022OHT1
chronic myeloid leukemiMRDx BCR-ABL Test, MRDx BCR-ABL Test SoftwareMolecularmd CorporationK17349212/22/2017OHT7
chronic myeloid leukemiQXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc.K18166102/13/2019OHT7
chronic myeloid leukemiXpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheidK19007609/27/2019OHT7
chronic myeloid leukemiBCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd.K22186909/05/2023OHT7
chronic myeloid leukemiaQuantidex qPCR BCR-ABL IS KitAsuragen, Inc.DEN16000307/22/2016OHT7
chylous ascitesBD Curve Ascites ShuntCare FusionK17040511/02/2017OHT3
coarctation of the aortaCHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)NuMED, Inc.P15002803/25/2016OHT2
coarctation of the aortaMinima Stent SystemRenata Medical, Inc.P24000308/28/2024OHT2
coccidioidomycosisGeneSTAT.MDx Coccidioides AssayDxna, LLCDEN17004111/29/2017OHT7
compartment syndromeAccuryn Monitoring SystemPotrero Medical, Inc.K15365504/15/2016OHT3
compartment syndromeAccuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 FPotrero Medical, Inc.K22102001/13/2023OHT3
compartment syndromeTraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLCK24005704/17/2024OHT3
compartment syndromeRENASYS F/-AB ABDOMINAL WOUND DRESSING KITSmith & Nephew, Inc.K10078709/17/2010OHT4
compartment syndromeRENASYS AB ABOMINAL DRESSING KITSmith & Nephew, Inc.K11278411/22/2011OHT4
compartment syndromeABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMKci USA, Inc. (Kinetic Concepts, Inc.)K12049910/05/2012OHT4
compartment syndromeAVANCE® FOAM ABDOMINAL DRESSING KITMolnlycke Health CareK13085204/14/2014OHT4
compartment syndromeRENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port DeviceSmith & Nephew, Inc.K14313307/23/2015OHT4
compartment syndromeAvance Abdominal Dressing KitMolnlycke Health Care Us, LLCK16193911/17/2016OHT4
compartment syndromeV.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.)K16279001/26/2017OHT4
compartment syndromeRENASYS Y-Connector; RENASYS TOUCHSmith & Nephew Medical LimitedK18120401/10/2019OHT4
compartment syndromeRENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical LimitedK18182203/21/2019OHT4
compartment syndromeInvia Abdominal Dressing KitMedela AGK18219102/01/2019OHT4
compartment syndromeXLR8 Abdominal Wound Dressing KitGenadyne BiotechnologiesK18272209/27/2019OHT4
compartment syndromeV.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business GroupK20331610/27/2021OHT4
compartment syndromeTraumaGuard Intra-abdominal Pressure Sensing SystemSentinel Medical Technologies, LLCK21057010/29/2021OHT4
compartment syndromeRenasys Edge (66803126)Smith & Nephew Medical LimitedK22304111/22/2022OHT4
compartment syndromeRenasys EdgeSmith & Nephew Medical, Ltd.K23193905/24/2024OHT4
compartment syndromeRENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K26064605/27/2026OHT4
compartment syndromeTWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEMTwin Star Medical, Inc.K13196602/07/2014OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K19332107/30/2020OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K20263512/10/2020OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K21052504/22/2021OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K22095205/24/2022OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K24299703/13/2025OHT6
compartment syndromeMY01 Continuous Compartmental Pressure MonitorMY01, Inc.K25190001/16/2026OHT6
compartment syndrome; cyanide poisoning; gas gangrene; myonecrosis; osteomyelitisRectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.K15222304/29/2016OHT1
compartment syndrome; cyanide poisoning; gas gangrene; myonecrosis; osteomyelitisOxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K16310903/22/2017OHT1
congenital adrenal hyperplasiaGSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UWallac OYK10068207/23/2010OHT7
congenital methemoglobinemiaStat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK18018608/23/2018OHT7
corticobasal degeneration; dementia with Lewy bodies; multiple system atrophy; progressive supranuclear palsyneuropacsAutomated Imaging Diagnostics, LLCDEN24007104/03/2026OHT5
craniofacial dysostosisLEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStrykerK12123501/09/2014OHT1
craniosynostosisTHE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEMStryker CraniomaxillofacialK09274301/15/2010OHT1
craniosynostosisCRANIAL REMOLDING ORTHOSISOrthotic Care Services, LlpK11124708/15/2011OHT5
craniosynostosisKidCapEastern Cranial Affiliates, LLCK18056810/16/2018OHT5
craniosynostosisCranioXpandKLS-Martin L.P.K23021111/21/2023OHT5
craniosynostosisInion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OYK25147207/11/2025OHT5
craniosynostosis; syndromic craniosynostosisOSTEOMED CRANIAL DISTRACTION SYSTEMOsteomedK12130408/22/2012OHT5
craniosynostosis; syndromic craniosynostosisOSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOROsteomed LPK12388506/03/2013OHT5
cryptococcosisCRAG LATERAL FLOW ASSAY (CRAG LFA)Immuno-Mycologics, Inc.K10228607/20/2011OHT7
cryptococcosisCRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.K11242203/28/2012OHT7
cryptococcosisALPHA CRYPTOCOCCAL ANTIGEN EIAImmuno-Mycologics, Inc.K12094612/17/2012OHT7
cutaneous leishmaniasis; leishmaniasisSMART LEISH, MODEL LGM1-050U.S. Army Medical Research Institute of InfectiousK08186805/25/2011OHT7
cutaneous leishmaniasis; leishmaniasisCL DETECT RAPID TESTInBios International, Inc.K14134111/14/2014OHT7
cystic fibrosisFREQUENCER MODEL V2XDymedso, Inc.K10074908/31/2010OHT1
cystic fibrosisFREQUENCERDymedso, Inc.K10317601/26/2011OHT1
cystic fibrosisQUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZERQuality Life Technologies Co;LtdK11282406/21/2012OHT1
cystic fibrosisVIBRALUNG ACOUSTICAL PERCUSSORWestmed, Inc.K13305705/23/2014OHT1
cystic fibrosisAEROSURE MEDICActegy , Ltd.K14077212/19/2014OHT1
cystic fibrosisBREATH SHAKECheen Houng Ent. Co. , Ltd.K12158711/22/2013OHT1
cystic fibrosisMacroduct Advanced Model 3710Elitechgroup, Inc.K18062707/27/2018OHT5
cystic fibrosisNHANES WHOLE BODY DXA REFERENCE DATABASEHologic, Inc.K10326503/16/2011OHT8
cystic fibrosisLunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK25271804/20/2026OHT8
cystic fibrosisGSP NEONATAL IRT KIT (3306-001U)Wallac Oy, Subsidiary of PerkinelmerK10241912/16/2010OHT7
cystic fibrosisAUTODELFIA NEONATAL IRT KITWallac Oy, A Subsidiary of Perkinelmer, Inc.K11027406/10/2011OHT7
cystic fibrosisCLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRICWescor, Inc.K12182303/27/2013OHT7
cystic fibrosisVITROS Chemistry Products Cl- SlidesOrtho Clinical DiagnosticsK16202012/16/2016OHT7
cystic fibrosisStat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK18042808/15/2018OHT7
cystic fibrosisSynermed ISE ReagentsInfrared Laboratory Systems, LLC (Dba Synermed)K18120107/10/2018OHT7
cystic fibrosisGEM Premier ChemSTATInstrumentation Laboratory COK18354902/16/2019OHT7
cystic fibrosisi-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K18368802/07/2020OHT7
cystic fibrosisEasyStat 300Medica CorporationK22039609/26/2023OHT7
cystic fibrosisILLUMINA MISEQDX  CYSTIC FIBROSIS 139-VARIANT ASSAYIllumina, Inc.K12400611/19/2013OHT7
cystic fibrosisILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAYIllumina, Inc.K13275011/19/2013OHT7
cystic fibrosisxTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRLuminex Molecular Diagnostics, Inc.K16333612/15/2016OHT7
cystic fibrosisxTAG Cystic Fibrosis 39 Kit v2Luminex Molecular Diagnostics, Inc.K16334712/15/2016OHT7
cystic fibrosis; islet cell carcinomaLIASYS 450AmsK11313103/08/2012OHT7
cystic fibrosis; pancreatic islet cell carcinomaI-STAT 1 WIRELESS ANALYZERAbbott Point of Care, Inc.K10319502/08/2011OHT7
cystic fibrosis; pancreatic islet cell carcinomaACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K11325305/17/2012OHT7
cystic fibrosis; pancreatic islet cell carcinomaACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULEAlfa Wassermann Diagnostic Technologies, Inc.K12301804/23/2013OHT7
cystic fibrosis; pancreatic islet cell carcinomaXL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJas Diagnostics, Inc.K13091505/15/2014OHT7
cystic fibrosis; pancreatic islet cell carcinomaVITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K18207210/30/2018OHT7
cystic fibrosis; pancreatic islet cell carcinomai-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K21095808/13/2021OHT7
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deficiency of aromatic-L-amino-acid decarboxylase (AADC deficiency)SmartFlow Neuro CannulaClearPoint Neuro, Inc.DEN24002311/13/2024OHT5
dementia with Lewy bodiescNeuro cDATCombinostics OYK23390807/01/2024OHT8
dermatomyositis; mixed connective tissue disease; polymyositis; progressive systemic sclerosisGOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KITGold Standard DiagnosticsK13133001/28/2014OHT7
dermatomyositis; mixed connective tissue disease; polymyositis; sclerodermaEliA SymphonyS ImmunoassayPhadia ABK19071011/29/2019OHT7
dermatomyositis; mixed connective tissue disease; polymyositis; systemic sclerosisQUANTA FLASH ENA7Inova Diagnostics, Inc.K12292305/07/2013OHT7
dermatomyositis; mixed connective tissue disease; polymyotitis; systemic sclerosisEUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)Euroimmun USK14022412/09/2014OHT7
dermatomyositis; mixed connective tissue diseases; polymyositis; progressive systemic sclerosisANA SCREEN ELISA (IGG)Euroimmun USK13118507/15/2013OHT7
dermatomyositis; polymyositis; systemic sclerosisAlegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSBZeus ScientificK25081405/08/2026OHT7
dialysis-related amyloidosisKANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMNKaneka Pharma America, LLCH13000103/05/2015OHT3
differentiated thyroid cancerAccess ThyroglobulinBeckman Coulter, Inc.K22097209/15/2023OHT7
differentiated thyroid cancerElecsys Tg IIRoche DiagnosticsK22189009/30/2023OHT7
differentiated thyroid cancerAccess ThyroglobulinBeckman Coulter, Inc.K24092706/28/2024OHT7
differentiated thyroid cancerAccess ThyroglobulinBeckman Coulter, Inc.K24142306/07/2024OHT7
differentiated thyroid cancerAtellica IM Thyroglobulin (Tg)Siemens Healthcare Diagnostics, Inc.K24298106/20/2025OHT7
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeBostonSight PD Prosthetic DeviceBostonsightK16146107/25/2016OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeBOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, IncorporatedK17140407/17/2017OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeOPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensContamac, Ltd.K18061604/25/2018OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeBoston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, IncorporatedK18316702/12/2019OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeBostonSight ScleralBostonsightK18317501/04/2019OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeOptimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd.K21263103/17/2022OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeVisionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A)Visionary Optics, LLCK22339412/07/2022OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeNewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral LensAcculens, Inc.K23091006/16/2023OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeVisionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLCK23332502/21/2024OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeAcuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K24061804/03/2024OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeSDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K24139810/22/2024OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeBostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK24157108/14/2024OHT1
ectodermal dysplasia; familial dysautonomia; graft-versus-host disease; Johnson syndrome; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degeneration; Stevens-Johnson syndromeAcuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K24239311/01/2024OHT1
epidemic typhus; Rickettsia infection; Rocky mountain spotted fever; spotted fever; typhusRickettsia Real-time PCR AssayCenters For Disease Control and Prevention (CDC)K17094006/29/2017OHT7
epispadiasFirlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral StentCook IncorporatedK17227811/22/2017OHT3
esophageal carcinomaPILLING ESOPHAGEAL BOUGIESTeleflexmedical, Inc.K13343906/16/2014OHT3
factor IX deficiency; hemophilia BCRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K21400212/23/2022OHT7
factor VIII deficiency; hemophilia ACryocheck Chromogenic Factor VIIIPrecision BiologicK19320407/17/2020OHT7
factor VIII deficiency; hemophilia ACRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc.K22283109/13/2023OHT7
factor VIII deficiency; hemophilia ACRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K25144008/25/2025OHT7
filariasisHydroven 12, Hydroven 12 GarmentsHuntleigh Healthcare , Ltd.K15222804/04/2016OHT2
focal segmental glomerulosclerosisLIPOSORBER(R) LA-15 SYSTEMKaneka Pharma America Corp.P910018/S02110/14/2016OHT3
focal segmental glomerulosclerosis; primary focal segmental glomerulosclerosisLIPOSORBER LA-15 SYSTEMKaneka Pharma America, LLCH12000510/10/2013OHT3
focal segmental glomerulosclerosis; primary focal segmental glomerulosclerosisLIPOSORBER LA-15 SystemKaneka Pharma America, LLCH17000203/20/2018OHT3
frontotemporal dementia; Hodgkin disease; Huntington's disease; Lewy body dementia; Small cell lung cancerImaging system of positron emission and X-ray computed tomography (DigitMI 930)Raysolution Healthcare Co., Ltd.K24126601/27/2025OHT8
frontotemporal dementia; Hodgkin disease; Huntington's disease; Lewy body dementia; non-Hodgkin lymphoma; small cell lung cancerOmni LegendGe Medical Systems Israel, Functional ImagingK24166508/08/2024OHT8
frontotemporal dementia; Hodgkin disease; Lewy body dementia; small cell lung cancerDiscovery MIGe Medical Systems, LLCK16157408/11/2016OHT8
frontotemporal dementia; Hodgkin disease; Lewy body dementia; small cell lung cancerDiscovery MI Gen2Ge Medical Systems, LLCK21184608/20/2021OHT8
frontotemporal dementia; Hodgkin disease; Lewy body dementia; small cell lung cancerOmni LegendGE HealthcareK22193209/02/2022OHT8
frontotemporal dementia; Lewy body dementiaXeleris 4.0 Processing and Review WorkstationGE HealthcareK15335503/16/2016OHT8
frontotemporal dementia; Lewy body dementiaXeleris V Processing and Review SystemsGE HealthcareK20110309/25/2020OHT8
frontotemporal dementia; Lewy body dementiaXeleris V Processing and Review SystemGE HealthcareK22168003/01/2023OHT8
galactosemiaSPOTCHECK NEONATAL GALT MICROPLATE REAGENT KITAstoria-Pacific, Inc.K10264307/15/2011OHT7
galactosemiaSPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITAstoria-Pacific, Inc.K12110106/20/2013OHT7
galactosemiaGSP NEONATAL TOTAL GALACTOSE KITWallac Oy, A Subsidiary of Perkinelmer, Inc.K13365204/28/2014OHT7
galactosemiaGSP Neonatal Total Galactose kitPerkinelmer, Inc.K19033511/06/2019OHT7
galactosemia; phenylketonuria; tyrosinemiaNEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350DAstoria-Pacific, Inc.K10139202/04/2011OHT7
gastric antral vascular ectasiaBARRX CHANNEL RFA ENDOSCOPIC CATHETERCovidien, LLCK13062307/26/2013OHT3
gastric antral vascular ectasiaBarrx SB RFA Endoscopic CatheterCovidien, LLCK17355901/18/2018OHT3
gastric antral vascular ectasiaAqua Medical RF Vapor SystemAqua Medical, Inc.K18359506/21/2019OHT3
gastric antral vascular ectasiaAqua Medical RF Vapor SystemAqua Medical, Inc.K21128205/27/2021OHT3
gastric antral vascular ectasiaRF Vapor SystemAqua Medical, Inc.K21362712/17/2021OHT3
gastric antral vascular ectasiaAqua Medical RF Vapor Ablation SystemAqua Medical, Inc.K24127112/12/2024OHT3
gastric antral vascular ectasiaAqua Medical RF Vapor Ablation SystemAqua Medical, Inc.K25122608/08/2025OHT3
gastric antral vascular ectasiaHALO ABLATION CATHETER, MODEL 90-9100Barrx Medical, IncorporatedK09300801/08/2010OHT4
gastric antral vascular ectasiaHALO ABLATION CATHETER MODEL 90-9100, HALO90 ULTRA ABLATION CATHETER MODEL 90-9200Barrx Medical, Inc.K10111106/18/2010OHT4
gastric antral vascular ectasiaHALO60 ABLATION CATHETERBarrx Medical, Inc.K11245401/05/2012OHT4
gastric antral vascular ectasiaHALO90 ULTRA ABLATION CATHETERBarrx Medical, Inc.K12043105/03/2012OHT4
gastric antral vascular ectasiaC2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.K24045707/24/2024OHT4
gastric antral vascular ectasiaHybridAPC probeErbe Elektromedizin GmbHK24312006/20/2025OHT4
glioblastomai2ContourMrimath, LLCK23382208/08/2024OHT8
glioblastoma; glioblastoma multiformeOPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)Novocure, GmbHP100034/S01310/05/2015OHT5
glioblastoma; glioblastoma multiformeNOVOCURE LTD'S NOVOTTF-100A TREATMENT KITNovocure, GmbHP10003404/08/2011OHT5
glioblastoma; meningioma; trigeminal neuralgia; vestibular schwannomaLEKSELL GAMMA KNIFE PERFEXIONElekta Instrument ABK13356505/09/2014OHT8
glomerulonephritis; primary membranous glomerulonephritisEUROIMMUN ANTI-PLA2R IFAEuroimmun USDEN14000205/29/2014OHT7
graft versus host diseaseRaycell Mk2Best Theratronics LimitedK16132408/12/2016OHT8
graft versus host diseaseSANGRAYHitachi , Ltd.K17208710/27/2017OHT8
graft versus host diseaseRaycell MK1Best Theratronics LimitedK18173701/02/2019OHT8
graft vs host diseaseRadGil2R3 X-Ray L.L.CK20117708/17/2020OHT8
graft vs host disease; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degenerationCustom Stable(TM) Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.K17033503/24/2017OHT1
graft vs host disease; limbal stem cell deficiency; neurotrophic keratitis; pellucid marginal degenerationCustom Stable Rigid Gas Permeable Scleral Contact LensValley Contax, Inc.K21388001/07/2022OHT1
granulomatosis with polyangiitisQUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMInova Diagnostics, Inc.K11254507/31/2012OHT7
hemicrania continua; paroxysmal HemicraniagammaCore SapphireElectrocore, Inc.K21185609/10/2021OHT5
hemolytic disease of the newbornTotal Bilirubin2Abbott Ireland Diagnostics DivisionK22332412/29/2022OHT7
hemophilia ACRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc.K18344003/12/2019OHT7
hemophilia AAAV5 DetectCDxARUP LaboratoriesP19003306/29/2023OHT7
hemophilia A; hemophilia BConcizuTrace™ ELISARandox Laboratories, Ltd.DEN24003505/22/2025OHT7
hemophilia B; severe hemophilia BnAbCyte Anti-AAVRh74var HB-FE AssayLabcorp Drug DevelopmentH23000504/25/2024OHT7
hepatocellular carcinomaTheraBionic P1Therabionic, Inc.H22000109/26/2023OHT4
hepatocellular carcinomaLiver SuiteGE Medical Systems SCSK21118005/02/2022OHT8
hepatocellular carcinomaTheraSphereBoston Scientific CorporationP20002903/17/2021OHT8
hepatocellular carcinomaSIR-Spheres Y-90 resin microspheresSirtex Medical, Inc.P990065/S01407/01/2025OHT8
hepatocellular carcinomaUTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONWako Chemicals USA, Inc.K10046402/23/2011OHT7
hepatomaEMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERESCelonova Biosciences, Inc.K14120908/07/2014OHT2
hepatomaONCOZENE MicrospheresVarian Medical Systems, Inc.K24279410/16/2024OHT2
hepatomaEmbozene Color-Advanced MicrospheresBoston ScientificK18010204/19/2018OHT3
hepatomaUniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K23155411/14/2023OHT3
hepatomaEmbozene Color-Advanced MicrospheresVarian Medical Systems, Inc.K24260801/17/2025OHT3
hepatomaQuadraSphere MicrospheresBiosphere Medical, S.A.K15118707/27/2015OHT5
hepatomaQuadraSphere MicrospheresBiosphere Medical, S.A.K15310211/23/2015OHT5
hepatomaQuadraSphere MicrospheresBiosphere Medical, S.A.K17237209/06/2017OHT5
hereditary nonpolyposis colorectal cancer; Lynch syndromeBOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.K21334802/21/2023OHT7
histoplasmosisALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102Immuno-Mycologics, Inc.K10140707/19/2011OHT7
homocystinuriaHOMOCYSTEINE TESTRocheK11379306/05/2012OHT7
homocystinuriaDIAZYME HOMOCYSTEINE POC TEST KITDiazyme LaboratoriesK12105307/31/2012OHT7
homocystinuriaST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.K12153306/15/2012OHT7
homocystinuriaVITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K12393005/15/2013OHT7
homozygous familial hypercholesterolemiaPlasma Delipidation System (PDS-2™ System)Hdl Therapeutics, Inc.H19000112/01/2020OHT3
hygromaBorvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc.K24145808/20/2024OHT5
hygromaEVACPhasor Health, LLCK24320506/03/2025OHT5
hygromaEVAC-MRIPhasor Health, LLCK25251411/05/2025OHT5
hypertrophic cardiomyopathyViz HCMViz. Ai, Inc.DEN23000308/03/2023OHT2
hypoparathyroidismADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare DiagnosticsK12198103/21/2013OHT7
hypoparathyroidismADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAYSiemens Healthcare Diagnostics, Inc.K13360102/05/2014OHT7
hypoparathyroidismADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K16365805/23/2017OHT7
hypoparathyroidismVITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK22119709/05/2023OHT7
hypoparathyroidismAccess Intact PTHBeckman Coulter, Inc.K23279103/01/2024OHT7
idiopathic inflammatory myopathies; systemic sclerosisQUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLSInova Diagnostics, Inc.K14165503/05/2015OHT7
idiopathic inflammatory myopathies; systemic sclerosisEliA Ro52, EliA Ro60Phadia ABK21090207/27/2022OHT7
idiopathic inflammatory myopathyQUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.K15142902/12/2016OHT7
idiopathic inflammatory myopathyQUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.K18097506/25/2018OHT7
idiopathic inflammatory myositis; mixed connective tissue disease; systemic sclerosisAptiva CTD Essential ReagentInova Diagnostics, Inc.K21340309/29/2023OHT7
idiopathic intracranial hypertensionRiver Stent System™Serenity Medical, Inc.H23000203/30/2026OHT5
idiopathic intracranial hypertension; pseudotumor cerebriMEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMMedtronic NeurosurgeryK12352402/13/2013OHT5
idiopathic pulmonary fibrosisFibresolveImvaria, Inc.DEN22004001/12/2024OHT8
idiopathic pulmonary fibrosisFibresolve (with PCCP)Imvaria, Inc.K25204111/07/2025OHT8
immunoglobulin Light-chain amyloidosis; monoclonal gammopathy of undetermined significance; Multiple MyelomaN Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbHK20149610/29/2021OHT7
immunoglobulin Light-chain amyloidosis; monoclonal gammopathy of undetermined significance; Multiple MyelomaN Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbHK21237903/02/2022OHT7
intracranial dural arteriovenous fistulas (dAVFsPHIL Liquid Embolic SystemMicroVention, Inc.H24000412/31/2025OHT5
kernicterusGEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TOInstrumentation Laboratory COK09362306/18/2010OHT7
kernicterusGEM PREMIER 4000Instrumentation Laboratory COK11299505/03/2012OHT7
kernicterusABL90 FLEXRadiometer Medical ApsK13269111/13/2014OHT7
kernicterusGEM PREMIER 4000Instrumentation Laboratory COK13340701/13/2014OHT7
kernicterusABL90 FLEX, ABL90 FLEX PLUSRadiometer Medical ApsK17088204/28/2017OHT7
kernicterus; pancreatic islet cell carcinomaGEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory COK16040212/14/2016OHT7
long QT syndromePCECG-1200 SYSTEM WITH MODULAR ECG ANALYSIS SYSTEM (MEANS)Norav Medical , Ltd.K11046311/10/2011OHT2
malariaID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test KitId-Fish Technology, Inc.DEN16002508/18/2017OHT7
malignant pleural mesotheliomaOptune LuaNovocure, GmbHH18000205/23/2019OHT4
measlesCAPTIA MEASLES IGMTrinity Biotech USAK14045505/22/2014OHT7
measles; rubellaBIOPLEX 2200 MMRV IGGBio-Rad LaboratoriesK09161603/29/2010OHT7
measles; rubellaBIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPLBio-Rad LaboratoriesK11107208/23/2011OHT7
measles; rubellaDYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc.K21276909/29/2023OHT7
mitral atresia; transposition of the great arteries; tricuspid atresiaZ-6 Atrioseptostomy CatheterNuMED, Inc.K21191007/19/2021OHT2
mixed connective tissue diseaseMaverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K19108510/25/2019OHT7
mixed connective tissue disease; progressive systemic sclerosisEUROIMMUN ANTI-ENA POOL ELISA (IGG)Euroimmun USK11299604/09/2013OHT7
monoclonal gammopathy of undetermined significance; Multiple MyelomaDiazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K25335812/19/2025OHT7
multiple myeloma; myelomaKYPH X HV-R BONE CEMENTMedtronic, Inc.K09382808/12/2010OHT6
multiple myeloma; myelomaKYPHON XPEDE BONE CEMENTMedtronicK10239702/28/2011OHT6
multiple myeloma; myelomaKYPHON (R) HV-R(R) Bone CementMedtronic Sofamor Danck USA, Inc.K15046004/28/2015OHT6
multiple myeloma; myelomaKYPHON XPEDE Bone CementMedtronicK15122711/16/2015OHT6
multiple myeloma; myelomaKyphon HV-R Bone CementMedtronic, Inc.K16098308/24/2016OHT6
multiple myeloma; myelomaKyphon Xpede Bone CementMedtronic, Inc.K16303202/27/2017OHT6
multiple myeloma; myelomaKYPHON HV-R Bone CementMedtronic Sofamor Danek USA, Inc.K18070005/18/2018OHT6
multiple myeloma; myelomaKYPHON VuE Bone CementTecres S.P.A.K22013104/18/2022OHT6
muscular dystrophy; polioHIROLLER ELEVATING WHEELCHAIRMax Mobility, LLCK10283712/23/2010OHT5
muscular dystrophy; polioC-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KGAat Alber Antriebstechnik GmbHK10312212/30/2010OHT5
muscular dystrophy; polioC-MAX+ (PLUS)Aat Alber Antriebstechnik GmbHK13086402/06/2014OHT5
muscular dystrophy; polioParaMotionPowerbasetec GmbHK20376101/21/2022OHT5
muscular dystrophy; polioGENESIS (MS-P02-GEN)Climbing Steps, Inc.K24084310/07/2024OHT5
myelomaSKELTEX ISVSkeltex Technologies, Inc.K09123402/16/2010OHT6
myelomaPARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICEArthrocare Corp.K10047909/21/2010OHT6
myelomaF20Teknimed, S.A.K10343301/03/2011OHT6
myelomaCOHESION BONE CEMENTTeknimed SasK10381602/04/2011OHT6
myelomaARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICEArthrocare Corp.K11018302/16/2011OHT6
myelomaAFFIRM (TM) VCF SYSTEMAlgea TherapiesK11099810/25/2011OHT6
myelomaCONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20GMedos International SARLK11290712/22/2011OHT6
myelomaACU-CUT VERTEBRAL AUGMENTATION SYSTEMAscendx Spine, Inc.K11345202/17/2012OHT6
myelomaVERTECEM II CEMENT KITAap Biomaterials GmbHK12187610/19/2012OHT6
myelomaMENDEC SPINE HV, MENDEC SPINE HV SYSTEMTecres S.P.A.K12217503/28/2013OHT6
myelomaSTRYKER IVAS BALLOON CATHETERStryker CorporationK12394204/03/2013OHT6
myelomaVertaplex® High Viscosity (HV) Radiopaque Bone CementStryker CorporationK15058206/12/2015OHT6
myelomaHIGH V+Teknimed SasK16111404/12/2017OHT6
myelomaCONCORD Plus Radiopaque Bone CementGlobus Medical, Inc.K16261801/23/2017OHT6
myelomaFORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc.K17226903/27/2018OHT6
myelomaVK100 Percutaneous Vertebral Augmentation SystemBonwrx, Ltd.K19240311/08/2019OHT6
myelomaVertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker CorporationK19281803/31/2020OHT6
myelomaCONFIDENCE Spinal Cement SystemDepuy Spine, Inc.K20183108/31/2020OHT6
myelomaSpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementStryker InstrumentsK21123806/25/2021OHT6
myelomaSpineJack® Expansion KitStryker InstrumentsK22329412/20/2022OHT6
myelomaXeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K24177509/18/2024OHT6
myelomaXeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K24353704/11/2025OHT6
myelomaVCFix Spinal SystemAmber ImplantsK25063705/30/2025OHT6
myelomaXeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K25189601/28/2026OHT6
myelomaPERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SAK25396605/01/2026OHT6
myelomeningoceleSEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEMZimmer Spine, Inc.K13198009/04/2013OHT6
myeloproliferative neoplasmipsogen JAK2 RGQ PCR KitQiagen, Inc.K17228701/12/2018OHT7
neurofibromatosis type 2NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANTCochlear AmericasP000015/S01206/13/2016OHT1
neuromyelitis opticaKRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayKronus, Inc.DEN15003004/25/2016OHT7
nevus of OtaJOULE MULTI-PLATFORM SYSTEMSciton, IncK10191603/18/2011OHT4
nevus of OtaQ-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6Advanced Technology Laser Co., Ltd.K10205007/29/2010OHT4
nevus of OtaCUTERA QSWITCH LASER SYSTEMCutera, Inc.K10295406/22/2011OHT4
nevus of OtaREVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTORHoya Photonics, Inc.K10311811/19/2010OHT4
nevus of OtaSPECTRA LASER SYSTEMLutronic CorporationK10345504/28/2011OHT4
nevus of OtaAPOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMBEIJING SYNTECH LASER CO., LTD.K11301812/14/2012OHT4
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nevus of OtaE-BEAM ND: YAG LASEREclipse Aesthetics, LLCK12292201/10/2013OHT4
nevus of OtaQYAG LASER SYSTEMPalomar Medical Technologies, Inc.K13025005/03/2013OHT4
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nevus of OtaREVLITE Q-SWITCHED ND:YAG LASER SYSTEMCynosure, Inc.K13325403/05/2014OHT4
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nevus of OtaHelios IIILaseroptek Co., Ltd.K15285606/02/2016OHT4
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nevus of OtaLucid Q-PTP / HWA 55Bison Medical Co, Ltd.K16167011/02/2016OHT4
nevus of OtaV30 system, V-Form Handpiece BC Medium applicatorViora , Ltd.K16236311/18/2016OHT4
nevus of OtaQ-Switched Nd:YAG Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co.K16312302/02/2017OHT4
nevus of OtaAlma QAlma Lasers , Ltd.K17085006/15/2017OHT4
nevus of OtaQ-Switched Nd:YAG Laser SystemIds, Ltd.K17107908/01/2017OHT4
nevus of OtaStarWalkerFotona D.O.O.K17122708/18/2017OHT4
nevus of OtaBM.IRISBluecore Co., Ltd.K17164809/08/2017OHT4
nevus of OtaQ-Switched Nd:YAG Laser SystemAmi, Inc.K17290812/07/2017OHT4
nevus of OtaCuRAS Nd:YAG LaserIlooda Co,., Ltd.K17303812/01/2017OHT4
nevus of OtaRapid FamilySharplight Technologies, Ltd.K17316911/20/2017OHT4
nevus of OtaHarmony XL Multi-Application PlatformAlma Lasers, Inc.K18129806/13/2018OHT4
nevus of OtaVydence Laser FamilyVydence Medical Industria E Comercio LtdaK19000703/01/2019OHT4
nevus of OtaQ-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.K19093606/17/2019OHT4
nevus of OtaMIINMedico USA, Inc.K19326601/22/2021OHT4
nevus of OtaNd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.K19347706/24/2020OHT4
nevus of OtaQ Switched Nd: YAG Laser machineBeijing Lead Beauty S & T Co., Ltd.K19360903/20/2020OHT4
nevus of OtaStarWalkerFotona D.O.O.K20217211/19/2020OHT4
nevus of OtaFinebeamSNJ Co., Ltd.K20228811/19/2021OHT4
nevus of OtaChromeQuanta System SpaK20250311/18/2020OHT4
nevus of OtaNd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.K20275811/16/2020OHT4
nevus of OtaVydence Zye and Vydence OneVydence Medical Industria E Comercio LtdaK20299810/26/2021OHT4
nevus of OtaPicoSure WorkstationCynosure, LLCK21022603/30/2021OHT4
nevus of OtaPicoreBio-Med USA, Inc.K21208210/06/2021OHT4
nevus of OtaHELIOS IV 785Laseroptek Co., Ltd.K21266306/09/2022OHT4
nevus of OtaHOLLYWOOD SPECTRA Laser SystemLutronic CorporationK21356902/04/2022OHT4
nevus of OtaPL-1 Skin Treatment SystemAVAVA, Inc.K21372606/28/2022OHT4
nevus of OtaHandPICOVydence Medical Industria E Comercio LtdaK22004105/05/2022OHT4
nevus of OtaSolonLmg Lasers Comercio, Importacao E Exportacao LtdaK22176601/05/2024OHT4
nevus of OtaIRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.K22178908/09/2022OHT4
nevus of OtaAlma HarmonyAlma Lasers, Inc.K23030803/01/2023OHT4
nevus of OtaLucas PlusAmt Engineering Co., Ltd.K23034005/04/2023OHT4
nevus of OtaHELIOS 785 PicoLaseroptek Co., Ltd.K23037305/22/2023OHT4
nevus of OtaMEDIYAGMedicreations, LLCK23194810/09/2024OHT4
nevus of OtaNd:Yag Laser Therapy SystemsBeijing Unt Technology Co., Ltd.K23253211/02/2023OHT4
nevus of OtaAlma HarmonyAlma Lasers, Inc.K23302402/08/2024OHT4
nevus of OtaOmnimax S3, Omnimax S4Sharplight Technologies, Ltd.K23330412/22/2023OHT4
nevus of OtaDEKA TOROEl.En S.P.A.K24075205/16/2024OHT4
nevus of OtaPastelle ProWontech Co., Ltd.K24152702/14/2025OHT4
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nevus of OtaQ Switched Nd:YAG Laser machine (QNHF-01)Beijing Nubway S&T Co., Ltd.K24294303/03/2025OHT4
nevus of OtaAlma HarmonyAlma Lasers, Inc.K24304404/11/2025OHT4
nevus of OtaHELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.K24378002/07/2025OHT4
nevus of OtaPICOALEXWontech Co., Ltd.K24395703/12/2025OHT4
nevus of OtaPastelleWontech Co., Ltd.K25016507/03/2025OHT4
nevus of OtaQ-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,LtdK25093606/12/2025OHT4
nevus of OtaTRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical IncorporatedK25146410/03/2025OHT4
nevus of OtaQ-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.K25231910/20/2025OHT4
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nevus of OtaVydence Family of LasersVydence Medical Industria E Commercio LtdaK25275301/24/2026OHT4
nevus of OtaCuRAS hybridClassys, Inc.K25312311/20/2025OHT4
nevus of OtaBELLUS-QSpeclipse, Inc.K25334411/25/2025OHT4
nevus of OtaVANISH PRODdc Technologies, Inc.K25376504/22/2026OHT4
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nevus of OtaNd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.K26037503/31/2026OHT4
osteochondritis dissecansORTHOSORB RESORBABLE PINSDePuy Orthopaedics, Inc.K11107707/12/2011OHT6
osteochondritis dissecansORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISOrtho Solutions LimitedK11167802/07/2012OHT6
osteochondritis dissecansOIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEMThe Orthopaedic Implant CompanyK11312301/12/2012OHT6
osteochondritis dissecansMAXTORQUE SCREW SYSTEMOrthohelix Surgical Designs, Inc.K13132405/31/2013OHT6
osteochondritis dissecansARTHREX COMPRESSION FT SCREWSArthrex, Inc.K13221711/25/2013OHT6
osteochondritis dissecansFIXOS SCREW SYSTEMStryker Trauma AGK13345102/28/2014OHT6
osteochondritis dissecansORTHOSORB LSBiomet, Inc.K14062504/18/2014OHT6
osteochondritis dissecansLife Spine Cannulated ScrewsLife Spine, Inc.K15012605/11/2015OHT6
osteochondritis dissecansArthrex Plates, Screws, and StaplesArthrex, Inc.K15045604/29/2015OHT6
osteochondritis dissecansArthrex RetroFusion ScrewArthrex, Inc.K15107805/15/2015OHT6
osteochondritis dissecansS4 Screw System™Subchondral SolutionsK16217109/07/2017OHT6
osteochondritis dissecansFuzeFix Screw SystemFusion Orthopedics, LLCK17003808/07/2017OHT6
osteochondritis dissecansArthrex Compression ScrewsArthrex, Inc.K17038205/11/2017OHT6
osteochondritis dissecansCannulated Screw Internal Fixation SystemLife Spine, Inc.K17328612/14/2017OHT6
osteochondritis dissecansArthrex Compression FT ScrewsArthrex, Inc.K18236112/18/2018OHT6
osteochondritis dissecansArthrex Compression FT PinsArthrex, Inc.K22083909/19/2022OHT6
osteochondritis dissecansOsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric TechnologiesK24269110/09/2024OHT6
osteogenesis imperfectaThe Simple Locking IntraMedullary (SLIM) SystemPega Medical, Inc.K14335507/10/2015OHT6
osteogenesis imperfectaThe Simple Locking Intramedullary (Slim) SystemPega Medical, Inc.K19271006/24/2020OHT6
osteogenesis imperfectaFassier-Duval Telescopic IM SystemPega Medical, Inc.K21129205/26/2021OHT6
osteogenesis imperfectaPediatric Nailing Platform | TibiaOrthoPediatrics Corp.K23126608/21/2023OHT6
osteogenesis imperfectaRODEO Telescopic NailOrthofix SrlK23264805/03/2024OHT6
osteogenesis imperfectaFassier-Duval Telescoping IM SystemOrthopediatrics Canada Ulc Dba Pega MedicalK24198302/21/2025OHT6
osteogenesis imperfectaPediatric Nailing Platform | Tibia Pediatric Nailing Platform | FemurOrthoPediatrics Corp.K25062304/01/2025OHT6
osteomyelitisCERAMENT GBonesupport ABDEN21004405/17/2022OHT6
osteomyelitisSYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLCK11143708/10/2011OHT6
osteomyelitisSTIMULAN KIT, STIMULAN RAPID CUREBiocomposites, Ltd.K14183001/23/2015OHT6
osteomyelitisORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KITOrthofix SrlK14205212/05/2014OHT6
osteomyelitisNuVasive X-CORE Mini Cervical Expandable VBR SystemNu Vasive, IncorporatedK15165109/25/2015OHT6
osteomyelitisC-VBRCardinal Spine, LLCK15256802/11/2016OHT6
osteomyelitisFORTIFY Corpectomy SpacersGlobus Medical, Inc.K16231511/09/2017OHT6
osteomyelitisFORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE SpacersGlobus Medical, Inc.K17184812/21/2017OHT6
osteomyelitisModulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.K17203211/20/2017OHT6
osteomyelitisTrabisColigne AGK17389309/06/2018OHT6
osteomyelitisFORTIFY Corpectomy SpacersGlobus Medical, Inc.K17398209/19/2018OHT6
osteomyelitisNuVasive Monolith Cervical Corpectomy SystemNu Vasive, IncorporatedK18055011/20/2018OHT6
osteomyelitisSANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLCK18066511/28/2018OHT6
osteomyelitisNormandy VBR SystemZavation Medical Products, LLCK18067307/13/2018OHT6
osteomyelitisT2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.K18132809/19/2018OHT6
osteomyelitisVLIFT-s Vertebral Body Replacement SystemStryker SpineK18307101/10/2019OHT6
osteomyelitisT2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.K18351001/16/2019OHT6
osteomyelitisChoice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespineK18358802/22/2019OHT6
osteomyelitisCOLOSSEUM MeshGlobus Medical, Inc.K19014705/08/2019OHT6
osteomyelitisALTA Anterior Cervical Corpectomy SystemAstura Medical, LLCK19042610/24/2019OHT6
osteomyelitisNormandy VBR SystemZavation Medical Products, LLCK19142308/06/2019OHT6
osteomyelitisSmall VBR™Ulrich GmbH & Co. KGK19211711/01/2019OHT6
osteomyelitisGalileo Vertebral Body Replacement DeviceBright SpineK19214504/21/2020OHT6
osteomyelitisNEXXT MATRIXX SystemNexxt Spine, LLCK19341202/24/2020OHT6
osteomyelitisNuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, IncorporatedK19350602/26/2020OHT6
osteomyelitisKONG-TL VBR System, KONG-C VBR SystemIcotec AGK20023505/29/2020OHT6
osteomyelitisF3D Corpectomy SystemCorelink, LLCK20263712/23/2020OHT6
osteomyelitisAvitus(r) Bone HarvesterAvitus Orthopaedics, Inc.K21063103/31/2021OHT6
osteomyelitisCAPRI Corpectomy Cage SystemK2m, Inc.K21132002/24/2022OHT6
osteomyelitisArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLCK21189210/06/2022OHT6
osteomyelitisMediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K21212604/04/2022OHT6
osteomyelitisGalileo Vertebral Body Replacement DeviceBright SpineK22154201/13/2023OHT6
osteomyelitisF3D Interbody SystemCorelink, LLCK23032906/06/2023OHT6
osteomyelitisAscend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.K23217310/06/2023OHT6
osteomyelitisRIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK23248110/13/2023OHT6
osteomyelitisVADER® Pedicle SystemIcotec AGK23262802/26/2024OHT6
osteomyelitisKONG®-TL VBR System and KONG® C VBR SystemIcotec AGK23279004/04/2024OHT6
osteomyelitisicotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)Icotec AGK23279204/05/2024OHT6
osteomyelitisicotec Anterior Cervical Plate SystemIcotec AGK23321505/17/2024OHT6
osteomyelitisDOMINION Expandable Corpectomy SystemAstura MedicalK23335903/08/2024OHT6
osteomyelitisVADER® Pedicle System and VADER®one Pedicle SystemIcotec AGK24290002/27/2025OHT6
osteomyelitisCMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK25232711/12/2025OHT6
osteomyelitisAtlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K25256011/10/2025OHT6
osteomyelitisEffortMed PEEK Cages & Corpectomy CagesEffortmed, LLCK25268611/21/2025OHT6
osteomyelitisVyBrate™ VBR SystemVy Spine, LLCK25315801/07/2026OHT6
osteomyelitisCarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K25404503/16/2026OHT6
osteomyelitisOSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K26085005/12/2026OHT6
osteonecrosisMEDACTA BIPOLAR HEADMedacta International S.A.K09196703/02/2010OHT6
osteonecrosisOPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5TExactech, Inc.K09336001/11/2010OHT6
osteonecrosisAPEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)Omnlife ScienceK10015105/28/2010OHT6
osteonecrosisNOVATION CROWN CUP GXL LINERSExactech, Inc.K10026905/27/2010OHT6
osteonecrosisBIOPRO POLAR HEADBiopro, Inc.K10076112/03/2010OHT6
osteonecrosisEXACTECH EQUINOXE, PLATFORM FRACTURE STEMExactech, Inc.K10190908/02/2010OHT6
osteonecrosisNOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20Exactech, Inc.K10248711/08/2010OHT6
osteonecrosisNOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLEExactech, Inc.K10297511/05/2010OHT6
osteonecrosisEXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADSExactech, Inc.K10301211/10/2010OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K10311701/07/2011OHT6
osteonecrosisEXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TMExactech, Inc.K10341912/13/2010OHT6
osteonecrosisOPTERTRAK LOGIC PSC TIBIAL INSERTExactech SarasotaK11054704/14/2011OHT6
osteonecrosisEQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...Exactech, Inc.K11070804/01/2011OHT6
osteonecrosisENDO HEADMedacta InternationalK11114508/16/2011OHT6
osteonecrosisEQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHTExactech, Inc.K11137906/08/2011OHT6
osteonecrosisOPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENTExactech, Inc.K11140007/28/2011OHT6
osteonecrosisNOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELSerfK11157208/29/2011OHT6
osteonecrosisTREGOR DUAL MOBILITY ACETABULAR SYSTEMAston MedicalK11198110/12/2012OHT6
osteonecrosisCONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K11278012/15/2011OHT6
osteonecrosisEXACTECH EQUINOXE CAGE GLENOIDSExactech, Inc.K11330912/08/2011OHT6
osteonecrosisNOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12Exactech, Inc.K11332003/16/2012OHT6
osteonecrosisCONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K11337802/15/2012OHT6
osteonecrosisCONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)Conformis, Inc.K12006802/03/2012OHT6
osteonecrosisNEO CR KNEE SYSTEMPipeline OrthopedicsK12031304/20/2012OHT6
osteonecrosisEXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATEExactech, Inc.K12106712/06/2012OHT6
osteonecrosisOPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZExactech, Inc.K12130705/31/2012OHT6
osteonecrosisNOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREEExactech, Inc.K12139201/16/2013OHT6
osteonecrosisNOVATION LPI PRIME FEMORAL STEMExactech, Inc.K12168410/01/2012OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K12203309/27/2012OHT6
osteonecrosisNEO PS KNEE SYSTEMPipeline OrthopedicsK12250005/03/2013OHT6
osteonecrosisINTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELLExactech, Inc.K12279810/11/2012OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K12287001/14/2013OHT6
osteonecrosisEXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEMStelkast CompanyK12288308/05/2013OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K12299112/20/2012OHT6
osteonecrosisOPTETRAK LOGIC CRC TIBIAL INSERTExactech, Inc.K12334201/10/2013OHT6
osteonecrosisOPTETRAK LOGIC POROUS FEMORAL COMPONENTExactech, Inc.K12368703/20/2013OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEMConformis, Inc.K13101905/24/2013OHT6
osteonecrosisNEO KNEE SYSTEMPipeline OrthopedicsK13136810/03/2013OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K13146707/18/2013OHT6
osteonecrosisEXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHTExactech, Inc.K13157507/03/2013OHT6
osteonecrosisOPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTSExactech, Inc.K13216110/11/2013OHT6
osteonecrosisRING-LOK MODULAR BIPOLAR SYSTEMImplants International, Ltd.K13253902/07/2014OHT6
osteonecrosisITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.K13325601/09/2014OHT6
osteonecrosisITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEMConformis, Inc.K13356003/28/2014OHT6
osteonecrosisOPTETRAK LOGIC POROUS FEMORAL COMPONENTSExactech, Inc.K14030207/30/2014OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEMConformis, Inc.K14042305/27/2014OHT6
osteonecrosisEXACTECH TAPERED WEDGE FEMORAL STEMExactech, Inc.K14067406/30/2014OHT6
osteonecrosisITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.K14083306/30/2014OHT6
osteonecrosisALTEON 6.5MM BONE SCREWSExactech, Inc.K14179707/29/2014OHT6
osteonecrosisALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSETExactech, Inc.K14182108/28/2014OHT6
osteonecrosisExactech® Novation® Crown Cup®Exactech, Inc.K14196009/03/2015OHT6
osteonecrosisITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEMConformis, Inc.K14216111/14/2014OHT6
osteonecrosisNeo Total Knee SystemNew Era Orthopedics, LLCK14238812/05/2014OHT6
osteonecrosisiTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.K14240412/11/2014OHT6
osteonecrosisCI../..X liner for NOVAE Dual Mobility Acetabular CupSerfK14267501/15/2015OHT6
osteonecrosisKlassic BiPolar SystemTotal Joint OrthopedicsK14311301/28/2015OHT6
osteonecrosisExactech Alteon Monobloc Revision StemExactech, Inc.K15006607/20/2015OHT6
osteonecrosisExactech Optetrak Logic CCExactech, Inc.K15089005/29/2015OHT6
osteonecrosisExactech Optetrak Logic Enhanced AssemblyExactech, Inc.K15217009/03/2015OHT6
osteonecrosisiTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement SystemConformis, Inc.K15270410/21/2015OHT6
osteonecrosisOMNI Skirted HeadsOmni Life Science, Inc.K15291903/10/2016OHT6
osteonecrosisConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.K15321701/07/2016OHT6
osteonecrosisOptetrak Logic Metaphyseal ConesExactech, Inc.K15359503/25/2016OHT6
osteonecrosisExactech® Novation® Element Press-fit Femoral StemExactech, Inc.K15364908/31/2016OHT6
osteonecrosisiTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.K15372103/25/2016OHT6
osteonecrosisOptetrak One Logic Femoral ComponentsExactech, Inc.K15377603/10/2016OHT6
osteonecrosisiTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.K16002503/07/2016OHT6
osteonecrosisOptetrak Advanced PatellaExactech, Inc.K16048403/18/2016OHT6
osteonecrosisConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.K16136606/14/2016OHT6
osteonecrosisConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.K16166807/15/2016OHT6
osteonecrosisGENflex2 Total Knee SystemStelkast, Inc.K16222209/07/2016OHT6
osteonecrosisExactech® Equinoxe® Preserve StemExactech, Inc.K16272602/01/2017OHT6
osteonecrosisExactech® Alteon® HA Femoral StemExactech, Inc.K16273204/26/2017OHT6
osteonecrosisTruliant Femoral ComponentsExactech, Inc.K17024002/23/2017OHT6
osteonecrosisTahoe Uni Knee SystemConsensus Orthopedics, Inc.K17034410/05/2017OHT6
osteonecrosisExactech Equinoxe Stemless ShoulderExactech, Inc.K17338803/09/2018OHT6
osteonecrosisExactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.K17358303/12/2018OHT6
osteonecrosisGENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.K17387501/19/2018OHT6
osteonecrosisConformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.K18090605/16/2018OHT6
osteonecrosisExactech Alteon Monobloc Revision StemExactech, Inc.K18153209/04/2018OHT6
osteonecrosisBI-MENTUM dual mobility systemSerfK18174412/11/2018OHT6
osteonecrosisTruliant Porous Femoral ComponentsExactech, Inc.K18179409/28/2018OHT6
osteonecrosisTRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.K18234611/26/2018OHT6
osteonecrosisExactech Alteon Highly Polished Femoral StemExactech, Inc.K18246211/08/2018OHT6
osteonecrosisAlteon Acetabular Cup SystemExactech, Inc.K18250203/13/2019OHT6
osteonecrosisiTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.K19056208/08/2019OHT6
osteonecrosisExactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.K19089010/22/2019OHT6
osteonecrosisiNSitu Bipolar Hip SystemTheken Companies, LLCK19129709/17/2019OHT6
osteonecrosisExactech Equinoxe Humeral Augmented TraysExactech, Inc.K19156108/20/2019OHT6
osteonecrosisExactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.K19209704/29/2020OHT6
osteonecrosisiTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.K20102306/16/2020OHT6
osteonecrosisiTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee ReplacementConformis, Inc.K20344712/22/2020OHT6
osteonecrosisBI-MENTUM™ ALTRX® Dual Mobility LinerDepuy Ireland UCK20353204/28/2021OHT6
osteonecrosisIdentity Imprint Knee Replacement SystemConformis, Inc.K21019105/06/2021OHT6
osteonecrosisiTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement SystemConformis, Inc.K21025202/17/2021OHT6
osteonecrosisiTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.K21080905/12/2021OHT6
osteonecrosisExactech® Equinoxe® Laser Cage GlenoidExactech, Inc.K21235603/04/2022OHT6
osteonecrosisIdentity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc.K21241109/23/2021OHT6
osteonecrosisIdentity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.K21338911/10/2021OHT6
osteonecrosisIdentity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc.K22105905/10/2022OHT6
osteonecrosisExactech® Alteon® Short Tapered WedgeExactech, Inc.K22132305/19/2023OHT6
osteonecrosisIdentity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)Conformis, Inc.K22140407/26/2022OHT6
osteonecrosisTRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.K22325207/17/2023OHT6
osteonecrosisIdentity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement SystemConformis, Inc.K22331607/21/2023OHT6
osteonecrosisNovae® Dual Mobility System, Hype® Hip SystemSerfK22374512/22/2023OHT6
osteonecrosisExactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.K22383309/14/2023OHT6
osteonecrosisIdentity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertConformis, Inc.K23084404/27/2023OHT6
osteonecrosisiTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.K23084607/17/2023OHT6
osteonecrosisIdentity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.K23123305/26/2023OHT6
osteonecrosisTRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.K23211404/04/2024OHT6
osteonecrosisIdentity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertsConformis, Inc.K23242609/08/2023OHT6
osteonecrosisEquinoxe® Central Screw Baseplate SystemExactech, Inc.K23348207/18/2024OHT6
osteonecrosisExactech® TRULIANT® Knee SystemExactech, Inc.K24039310/03/2024OHT6
osteonecrosisACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.K24066906/20/2024OHT6
osteonecrosisEquinoxe® Shoulder SystemExactech, Inc.K24344808/01/2025OHT6
osteonecrosisMaxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K24363408/25/2025OHT6
osteonecrosisiTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.K24376803/27/2025OHT6
osteonecrosisAlteon® HA Femoral StemsExactech, Inc.K24383903/10/2025OHT6
osteonecrosisEquinoxe® Shoulder SystemExactech, Inc.K26058304/14/2026OHT6
osteonecrosisTahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus OrthopedicsK26079604/02/2026OHT6
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pancreatic cancerVITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical DiagnosticsK23152508/09/2023OHT7
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pancreatic islet cell carcinomaEASYRA GLU-T REAGENT, EASYRA GLU-H REAGENTMedica Corp.K10018705/05/2010OHT7
pancreatic islet cell carcinomaELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS  ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2Seppim S.A.S.K10052512/15/2010OHT7
pancreatic islet cell carcinomaDIATRON PICTUS 400Diatron GroupK10174101/25/2011OHT7
pancreatic islet cell carcinomaIVD-GE02Sphere Medical , Ltd.K10194703/16/2011OHT7
pancreatic islet cell carcinomaPENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTHORIBA ABX SASK10378811/08/2011OHT7
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pancreatic islet cell carcinomaINDIKOThermofisher Scientific OYK11003506/28/2011OHT7
pancreatic islet cell carcinomaBIOLIS 12ITokyo Boeki Medisys, Inc.K11052003/23/2012OHT7
pancreatic islet cell carcinomaBS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZERShenzhen Mindray Bio-Medical Electronics Co., Ltd.K11237703/23/2012OHT7
pancreatic islet cell carcinomaAU5800(R) CHEMISTRY ANALYZERBeckman Coulter, Inc.K11241212/23/2011OHT7
pancreatic islet cell carcinomaDIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare DiagnosticsK11299911/22/2011OHT7
pancreatic islet cell carcinomaALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTEAlere San Diego Inc. Dba Biosite,Innovacon,HemosenK12061505/15/2013OHT7
pancreatic islet cell carcinomaUNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)Beckman Coulter, Inc.K13118904/17/2014OHT7
pancreatic islet cell carcinomaCAROLINA LIQUID CHEMISTRIES CLC 6410  CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CARCarolina Liquid Chemistries Corp.K13351905/16/2014OHT7
pancreatic islet cell carcinomaCARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEMPolymer Technology Systems, Inc.K14006805/22/2015OHT7
pancreatic islet cell carcinomaBioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test SystemPolymer Technology Systems, Inc.K14230210/02/2014OHT7
pancreatic islet cell carcinomaCardioChek Plus Test SystemPolymer Technology Systems, Inc.K15153007/07/2015OHT7
pancreatic islet cell carcinomaSynermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerInfrared Laboratory Systems, LLC (Dba Synermed)K15369206/24/2016OHT7
pancreatic islet cell carcinomai-Stat Alinity System with i-Stat Glucose testAbbott Point of Care, Inc.K16327104/10/2017OHT7
pancreatic islet cell carcinomaVITROS Chemistry Products GLU SlidesOrtho Clinical DiagnosticsK16343309/18/2017OHT7
pancreatic islet cell carcinomaALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEMAbbott LaboratoriesK17031610/19/2017OHT7
pancreatic islet cell carcinomaPTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts DiagnosticsK18278112/21/2018OHT7
pancreatic islet cell carcinomaGEM Premier ChemSTATInstrumentation Laboratory COK18354602/16/2019OHT7
pancreatic islet cell carcinomai-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K18367802/07/2020OHT7
pancreatic islet cell carcinomaVITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc.K19052004/03/2019OHT7
pancreatic islet cell carcinomaCardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts DiagnosticsK19340602/26/2022OHT7
pancreatic islet cell carcinomaStat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK20034903/13/2020OHT7
pancreatic islet cell carcinomaMedicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct BilirubinMedicon Hellas S.AK20089809/21/2021OHT7
pancreatic islet cell carcinomaNova Primary Glucose Analyzer SystemNova Biomedical CorporationK20354910/18/2022OHT7
pancreatic islet cell carcinomaCholestech LDX ™ SystemAlere San Diego, Inc.K22317909/20/2023OHT7
pancreatic islet cell carcinomai-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K22371007/28/2023OHT7
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pancreatic islet cell carcinomaGlucose2Abbott IrelandK25235710/24/2025OHT7
pancreatic islet cell carcinomaABL90 FLEX PLUS SystemRadiometer Medicals ApsK25248805/01/2026OHT7
pancreatic islet cell tumorStat Profile Prime Plus Analyzer SystemNova Biomedical CorporationK18034009/26/2018OHT7
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pellucid marginal degenerationTYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSThe Lagado Corp.K10215401/21/2011OHT1
pellucid marginal degenerationMENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSMenicon Co, Ltd.K10356102/03/2011OHT1
pellucid marginal degenerationFLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THINParagon Vision SciencesK12099606/28/2012OHT1
pellucid marginal degenerationEYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSESAdvanced Vision TechnologiesK15272404/27/2016OHT1
pellucid marginal degenerationBostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For SightK15306602/09/2016OHT1
pellucid marginal degenerationOptimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd.K16110008/10/2016OHT1
pellucid marginal degenerationAcuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K16200512/08/2016OHT1
pellucid marginal degenerationAcuity 18 (enflufocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K16325401/18/2017OHT1
pellucid marginal degenerationAcuity 85 (Oprifocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K17000106/02/2017OHT1
pellucid marginal degenerationAcuity 58 (Enflufocon B) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K17000705/31/2017OHT1
pellucid marginal degenerationENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd.K17157510/24/2017OHT1
pellucid marginal degenerationFluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEGParagon Vision SciencesK18017203/16/2018OHT1
pellucid marginal degenerationAcuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K18098806/08/2018OHT1
pellucid marginal degenerationeLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-KE&E Optics, Inc.K18157907/26/2018OHT1
pellucid marginal degenerationAcuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K20357104/09/2021OHT1
pellucid marginal degenerationAcuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K21353812/30/2021OHT1
pellucid marginal degenerationAcuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K23096506/16/2023OHT1
pellucid marginal degenerationGPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K25382203/27/2026OHT1
pemphigus vulgarisEUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG)Euroimmun Us, Inc.K09196909/02/2010OHT7
pernicious anemiaAccess Intrinsic Factor AbBeckman Coulter, Inc.K24080005/03/2024OHT7
pernicious anemia; primary biliary cholangitis; Type I autoimmune hepatitisHistofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K18020210/19/2018OHT7
pertussisILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMAMeridian Bioscience, Inc.K13367303/25/2014OHT7
pertussisFilmArray Respiratory Panel EZ (RP EZ)Biofire Diagnostics, LLCK15257910/03/2016OHT7
pertussisARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK16362605/02/2017OHT7
pertussisSimplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK17349808/13/2018OHT7
pertussisSolana Bordetella Complete AssayQuidel CorporationK18102907/15/2018OHT7
pertussisSimplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK18322312/19/2018OHT7
pertussisMBT SepsityperBruker Daltonik GmbHK19341912/27/2020OHT7
pertussisBIOFIRE SPOTFIRE Respiratory (R) PanelBiofire DiagnosticsK21395402/03/2023OHT7
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pertussiscobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.K24375311/20/2025OHT7
plague; pneumonic plagueJBAIDS PLAGUE DETECTION KITBiofire Diagnostics, Inc.K13172907/31/2013OHT7
pleural empyemaMEDELA THOPAZMedela AGK13021003/15/2013OHT4
pleural empyemaMEDELA THOPAZ+Medela AGK14155308/25/2014OHT4
pleural empyemaThoraguard SystemCentese, Inc.K18166711/29/2018OHT4
polycythemia veraipsogen JAK2 RGQ PCR KitQiagen, Inc.DEN16002803/27/2017OHT7
porokeratosis plantarisNUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAYNuance Medical, LLCK13099506/14/2013OHT4
porokeratosis plantarisCool RenewalCool Renewal, LLCK16129607/06/2016OHT4
porokeratosis plantarisCryoTouchCryoconcepts LPK18360104/18/2019OHT4
porokeratosis plantarisHydrozidMedilink A/SK20174007/07/2021OHT4
porokeratosis plantarisCryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitNuance Medical, LLCK21031010/22/2021OHT4
porokeratosis plantarisHydrozid PreciseBibawo Medical A/SK22189705/30/2023OHT4
porokeratosis plantarisHistofreezer VCryoconcepts LPK24010606/10/2024OHT4
priapismRigi10 Malleable Penile ProsthesisRigicon, Inc.K18167304/15/2019OHT3
primary biliary cholangitisQUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsInova Diagnostics, Inc.K16352509/05/2017OHT7
primary biliary cirrhosisEUROIMMUN ANTI-M2-3E ELISA (IGG)Euroimmun Us, Inc.K09273609/02/2010OHT7
primary biliary cirrhosisELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250Phadia US, Inc.K14137502/13/2015OHT7
primary biliary cirrhosisImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.K16313308/08/2017OHT7
primary biliary cirrhosisEliA M2 ImmunoassayPhadia ABK18155607/13/2018OHT7
primary lymphedemaLYMPHA PRESS 201MAX, MODEL 201MAXMego Afek AC , Ltd.K10067705/20/2010OHT2
primary lymphedemaWMI DVT WRAP, WMI THERMAL WRAP MODEL: D-1000F, D-1000C, T-2000A, T-2000B, T-2000KF, T-2000S, T-2000NWmi Enterprises, LLCK10096909/20/2010OHT2
primary lymphedemaPRACTICAL COMPRESSION DEVICE (PCD) 901A&901BMego Afek AC , Ltd.K12196210/19/2012OHT2
primary lymphedemaPCD 737AMego Afek AC , Ltd.K14064206/10/2014OHT2
primary lymphedemaFlexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)K15331109/14/2016OHT2
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primary lymphedemaLympha Press Optimal PlusMego Afek AC , Ltd.K18200302/27/2019OHT2
primary lymphedemaKoya RippleKoya, Inc.K19328806/16/2020OHT2
primary lymphedemaVariLymph 12 proSlk Medical GmbHK19347608/19/2020OHT2
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primary lymphedemaDayspringKoya Medical, Inc.K21088504/23/2021OHT2
primary lymphedemaAmputee Garment for use with Lympha Press Optimal PlusMego Afek AC , Ltd.K21405304/14/2022OHT2
primary lymphedemaAeroDVx Arm SystemSun Scientific, Inc.K22282309/07/2023OHT2
primary lymphedemaDayspringKoya Medical, Inc.K22322801/04/2024OHT2
primary lymphedemaPnueAira (PNCU-01)Biotab, LLCK25108608/18/2025OHT2
primary lymphedemaNanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K25426702/24/2026OHT2
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primary lymphedemaCOMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008Won Industrial Co.K10231901/28/2011OHT5
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primary lymphedemaCOMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMDaesung Maref Co., Ltd.K11244101/17/2012OHT5
primary lymphedemaCOMPRESSIBLE LIMB THERAPY SYSTEMWonjin Mulsan Co., Ltd.K11327502/27/2012OHT5
primary lymphedemaCOMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMWon Industrial Co.K12016605/14/2012OHT5
primary lymphedemaCOMPRESSIBLE LIMB SLEEVE SYSTEMMaxstar Industrial Co., Ltd.K13038502/18/2014OHT5
primary lymphedemaAir Compressible Limb Therapy SystemDaesung Maref Co., Ltd.K15003304/20/2015OHT5
primary lymphedemaLympha-Flow(LF1200)Daesung Maref Co., Ltd.K16017801/11/2017OHT5
primary lymphedemaPressure Therapy SystemXiamen Senyang Co., Ltd.K16190702/23/2017OHT5
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primary lymphedemaLF900Daesung Maref Co., Ltd.K20301906/22/2021OHT5
primary lymphedemaLF900Daesung Maref Co., Ltd.K23143707/19/2023OHT5
primary peritoneal carcinomaCUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK24049307/11/2024OHT3
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progressive multifocal leukoencephalopathySTRATIFY JCV(TM) ANTIBODYFocus Diagnostics, Inc.DEN12000801/20/2012OHT7
pulmonary arterial hypertensionVENTRIPOINT MEDICAL SYSTEMVentripoint, Inc.K14015303/06/2014OHT8
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pulmonary stenosisTYSHAK NUCLEUSNuMED, Inc.K12185908/31/2012OHT2
pulmonary stenosisBARD PTV DILATATION CATHETERC.R. Bard, Inc.K12236711/02/2012OHT2
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pulmonary tuberculosis; tuberculosisXPERT MTB/RIF ASSAYCepheidDEN13003207/25/2013OHT7
pulmonary tuberculosis; tuberculosisXpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80CepheidK14330202/12/2015OHT7
retinitis pigmentosaARGUS II RETINAL PROSTHESIS SYSTEMCortigent, Inc.H11000202/13/2013OHT1
retinopathy of prematurityRETCAM 3 OPTHALMIC IMAGING SYSTEMClarity Medical SystemsK10285904/20/2011OHT1
retinopathy of prematurityPASCAL STREAMLINE 577 (WITH ACCESSORIES)Topcon Medical Laser Systems, Inc.K11110808/11/2011OHT1
retinopathy of prematurityOPTO MITRA YELLOW LASEROpto Electronica SAK11164311/03/2011OHT1
retinopathy of prematuritySUPRA SCAN DELIVERY SYSTEMQuantel MedicalK12082509/14/2012OHT1
retinopathy of prematurityPASCAL LASER INDIRECT OPHTHALMOSCOPETopcon Medical Laser Systems, Inc. (Tmls)K12305611/13/2012OHT1
retinopathy of prematurityCRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESKeeler, Ltd.K13178712/23/2013OHT1
retinopathy of prematurityCONSTELLATION VISION SYSTEMAlcon Research, Ltd.K14106508/22/2014OHT1
retinopathy of prematurityEasyretQuantel MedicalK17006707/25/2017OHT1
retinopathy of prematurityIridex TruFocus LIO PremiereIridex CorporationK18166209/05/2018OHT1
retinopathy of prematurityRetCam 3 ; RetCam Shuttle ; RetCam PortableNatus Medical IncorporatedK18226309/07/2018OHT1
retinopathy of prematurityVitra 810Quantel MedicalK20150208/06/2020OHT1
retinopathy of prematurityCryoTreQVitreQ BVK20203812/30/2020OHT1
retinopathy of prematurityRetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K20350004/13/2021OHT1
retinopathy of prematurityVISION ONE LASER SYSTEMLumenis, Inc.K11121307/25/2011OHT4
retinopathy of prematurityVITRA MULTISPOTQuantel MedicalK12225101/24/2013OHT4
retinopathy of prematurityIridex TruFocus LIO PremiereIridex CorporationK17071805/03/2017OHT4
rubellaMAGO 4SDiamedix Corp.K09310101/21/2011OHT7
rubellaATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEMZeus Scientific, Inc.K09378407/16/2010OHT7
rubellaBIOPLEX 2200 TORC IGGBio-Rad Laboratories, Inc.K12057203/26/2012OHT7
rubellaVIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion IIBIOMERIEUXK14113307/09/2015OHT7
rubellaAlinity i Rubella IgGAbbott LaboratoriesK24316806/20/2025OHT7
rubella; Rubella infectionELECSYS RUBELLA IGM IMMUNOASSAYRoche DiagnosticsK09232203/12/2010OHT7
rubella; Rubella infectionLIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K12239709/06/2012OHT7
rubella; Rubella infectionAccess Rubella IgGBeckman Coulter, Inc.K25058811/17/2025OHT7
saccular intracranial aneurysmsPipeline Flex Embolization DeviceMicro Therapeutics, Inc. d/b/a ev3 NeurovascularP100018/S01512/14/2018OHT5
saccular intracranial aneurysmsPipeline Flex Embolization Device with Shield TechnologyMicro Therapeutics, Inc. d/b/a ev3 NeurovascularP100018/S02604/13/2021OHT5
saccular intracranial aneurysmsFlow Re-Direction Endoluminal Device (FRED®) SystemMicroVention, Inc.P18002712/16/2019OHT5
saccular intracranial aneurysmsFlow Re-Direction Endoluminal Device (FRED®) SystemMicroVention, Inc.P180027/S00209/16/2021OHT5
saccular intracranial aneurysmsSurpass Streamline Flow DiverterStryker NeurovascularP17002407/13/2018OHT5
saccular intracranial aneurysmsSurpass Evolve Flow Diverter SystemStryker NeurovascularP170024/S00305/20/2020OHT5
saccular intracranial aneurysmsWoven EndoBridge (WEB) Aneurysm Embolization SystemMicroVention, Inc.P17003212/31/2018OHT5
saccular intracranial aneurysmsLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.MicroVention, Inc.P17001305/30/2018OHT5
saccular intracranial aneurysmsLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.MicroVention, Inc.P170013/S00509/16/2021OHT5
saccular intracranial aneurysmsNeuroform Atlas® Stent SystemStryker NeurovascularP18003105/16/2019OHT5
saccular intracranial aneurysmsNeuroform Atlas® Stent SystemStryker NeurovascularP180031/S00107/30/2020OHT5
scleroderma (diffuse form)ELIA SCL-70S IMMUNOASSAYPhadia GmbHK14049310/30/2014OHT7
scleroderma; systemic sclerosisImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc.K17207803/30/2018OHT7
severe combined immunodeficiencyPERKINELMER ENLITE NEONATAL TREC TEST SYSTEMWallac OYDEN14001012/15/2014OHT7
severe combined immunodeficiency; X-linked agammaglobulinemiaEonis SCID-SMA kitPerkinelmer, Inc.K20303511/09/2022OHT7
sickle cell diseaseSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SETTerumobct, Inc.K13242912/06/2013OHT3
sickle cell diseaseSPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)Terumobct, Inc.K14193803/23/2015OHT3
sickle cell diseaseSpectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection AdapterTerumo BctK15136809/11/2015OHT3
sickle cell diseaseSpectra Optia Apheresis SystemTerumobct, Inc.K15360101/14/2016OHT3
sickle cell diseaseSpectra Optia Apheresis SystemTerumobct, Inc.K17259003/02/2018OHT3
sickle cell diseaseAMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterFresenius Kabi USA,LlcK18061512/04/2018OHT3
sickle cell diseaseSpectra Optia Apheresis SystemTerumobct, Inc.K18104911/01/2018OHT3
sickle cell diseaseSpectra Optia Apheresis SystemTerumobct, Inc.K18308102/05/2019OHT3
sickle cell diseaseAMICUS Separator SystemFresenius Kabi AGK19215011/13/2019OHT3
sickle cell diseaseAMICUS Separator SystemFresenius Kabi AGK20053009/11/2020OHT3
sickle cell disease; thalassemiaFerriSmart Analysis SystemResonance Health Analysis Services Pty, Ltd.K18221811/30/2018OHT8
sickle cell disease; thalassemiaLiverSmartResonance Health Analysis Services Pty, Ltd.K21377612/29/2021OHT8
silicosis; tuberculosisQuantiFERON®-TB Gold, QuantiFERON®-TB Gold PlusQiagenP010033/S04712/13/2021OHT7
slipped capital femoral epiphysisSYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)Synthes (Usa)K09290901/11/2010OHT6
slipped capital femoral epiphysisFREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)Pega Medical, Inc.K13159111/27/2013OHT6
slipped capital femoral epiphysisBIOMET CANNULATED SCREW SYSTEMBiomet, Inc.K14089106/03/2014OHT6
slipped capital femoral epiphysisMAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEMZimmer, Inc.K14244210/03/2014OHT6
slipped capital femoral epiphysisPHIN-FX Cannulated Lag Screw SystemAscent Medical, LLCK15069310/13/2015OHT6
slipped capital femoral epiphysisMetal Cannulated ScrewDouble Medical Technology, Inc.K22109001/10/2023OHT6
soft tissue sarcomaLUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMNucletron B.V.K14080306/26/2014OHT8
spinal muscular atrophyEonis SCID-SMA KitPerkinelmer, Inc.DEN20004411/09/2022OHT7
squamous cell carcinoma of the head and neckXVI R5.0Elekta LimitedK13196509/25/2013OHT8
squamous cell carcinoma of the head and neckPrecise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta LimitedK18213809/05/2018OHT8
superficial siderosisicobrain ariaIcometrix NVK24071211/07/2024OHT8
systemic lupus erythematosusEIA SMDP IMMUNOASSAYPhadia US, Inc.K13263108/29/2014OHT7
systemic mastocytosisIMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASEPhadia US, Inc.DEN12000102/15/2012OHT7
systemic mastocytosisImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control StripPhadia ABK17370403/02/2018OHT7
systemic sclerosisIMMULISA SCI-70 ANTIBODY ELISAImmco Diagnostics, Inc.K11314312/02/2011OHT7
systemic sclerosisQUANTA FLASH CENTROMEREInova Diagnostics, Inc.K12388002/07/2014OHT7
systemic sclerosisQUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsInova Diagnostics, Inc.K15263506/01/2016OHT7
systemic sclerosisEliA RNA Pol IIIPhadia ABK20254109/13/2021OHT7
thalassemiaVARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWAREBio-Rad Laboratories, Inc., Clinical Systems DivisK13086004/25/2013OHT7
thrombotic microangiopathy; thrombotic thrombocytopenic purpuraTechnozym ADAMTS13 ActivityTechnoclone Herstellung Von Diagnostika Und Arzneimitteln GMDEN23002402/28/2024OHT7
trigeminal neuralgiaMatreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.K22092009/07/2022OHT5
trigeminal neuralgiaSynergy Platform, Synergy, Infinity, VersaHDElekta LimitedK19224211/22/2019OHT8
trigeminal neuralgiaRT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose ReviewBrainlab AGK20368104/09/2021OHT8
trigeminal neuralgiaElekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta LimitedK21050006/11/2021OHT8
trigeminal neuralgiaEMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)Elekta Solutions ABK25218801/15/2026OHT8
tularemiaJBAIDS TULAREMIA DETECTION KITBiofire Diagnostics, Inc.K13193607/31/2013OHT7
tularemiaFrancisella tularensis Real-time PCR assayCenters for Disease Control and PreventionK25207209/30/2025OHT7
tularemiaFrancisella tularensis Real-time PCR AssayCenters for Disease Control and PreventionK26081203/30/2026OHT7
vulva carcinomaERBECRYO 2 Cryosurgical Unit with accessoriesErbe USA, Inc.K15104105/04/2015OHT4
vulvar intraepithelial neoplasiaLIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERSLightscalpel, LLCK12147107/10/2012OHT4

  • Medical devices for rare diseases were identified primarily based on their authorization date (devices authorized since January 1, 2010) and the inclusion of rare disease name(s) and/or synonym(s) in their publicly available FDA authorization and labeling information.
  • Many diseases, particularly rare diseases, lack unified terminology. Therefore, each rare disease can have many names and synonyms used by different entities. To help address this and given the large number of rare diseases, the FDA relied upon established rare disease resources for a list of currently known rare diseases that includes multiple names and synonyms when applicable. 
  • The list of rare disease names and synonyms used to identify a medical device authorized for a rare disease or condition was drawn from the Mondo rare disease subset (Monarch Initiative), filtered to diseases publicly listed by GARD (Diseases | GARD) or NORD (List of Rare Diseases | A-Z Database | NORD), as of June 2026. This initial list of identified devices was further refined by subject matter expert review of the disease indication and prevalence of the disease or condition. 
  • For Premarket Approval applications (PMAs) that are approved within the dates of interest, the first approval for a rare disease indication(s) through a PMA or PMA supplement, and any subsequent supplement(s) that expanded the rare disease indication(s), are listed. PMA supplements that do not expand the device use to a new rare disease indication are not listed.
  • All granted De Novos and 510(k)s cleared for a rare disease indication during the dates of interest are listed. Some of the listed 510(k)s may be modifications or updates to a previously cleared device for which there was no new rare disease indication cleared.

Resources for Rare Disease Medical Device Development

FDA programs and resources are available to support the development of medical devices for rare diseases, and the list below identifies some of the key resources. This list is not intended to be exhaustive.

General Device Development and Regulatory Support

FDA Pathway Specific to Small Patient Populations

  • Humanitarian Use Device (HUD) Designation 
    A designation for medical devices intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. HUD designation is a prerequisite for submitting a Humanitarian Device Exemption application. 
  • Humanitarian Device Exemption (HDE)
    A marketing application for devices with HUD designation that requires demonstration of safety and probable benefit but is exempt from certain effectiveness requirements. It is designed for devices intended for small patient populations where traditional clinical trials may not be feasible.

Programs That Expedite FDA Review

  • Breakthrough Devices Program
    A voluntary program that expedites the development and review of medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 
  • Safer Technologies Program (STeP)
    A voluntary program that expedites the development and review of certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics. Devices intended for a rare disease that is non-life threatening or is reasonably reversible for which the device offers meaningful safety improvements over current options may be eligible.
  • Total Product Life Cycle Advisory Program (TAP)
    A voluntary program that provides proactive, strategic FDA advice across the total product life cycle, from concept through commercialization. For devices intended for rare diseases, early and frequent engagement can help reduce regulatory uncertainty and support development planning.

Evidence and Innovation Tools

Initiatives and resources that support innovative evidence generation and emerging device categories.

  • Real-World Evidence (RWE)
    The FDA has multiple resources to support the appropriate use of real-world data (RWD) and real-world evidence (RWE) for medical device regulatory decision-making. Collection of RWD may be particularly relevant for rare diseases, where small patient populations can make traditional clinical trials challenging.
  • Digital Health Center of Excellence (DHCoE)
    The DHCoE advances and coordinates digital health efforts across the FDA and provides expertise and resources to support digital health innovation. Technologies such as remote monitoring, wearables, diagnostic software, and artificial intelligence-enabled tools may offer opportunities to support patients with a rare disease. 
  • Home as a Health Care Hub
    A CDRH initiative focused on advancing safe and effective medical devices designed for use in the home. Home-use technologies may help support ongoing care for patients with a rare disease while reducing the burden of frequent clinical visits.

FDA Rare Disease Innovation Hub (RDIH)

The Rare Disease Innovation Hub serves as a point of collaboration and connectivity among the FDA’s medical products centers – the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER) and CDRH – and with outside parties. The RDIH is focused on addressing cross-cutting issues in rare disease medical product development.

The Rare Disease Innovation Hub sponsors the Rare disease Innovation, Science, and Exploration (RISE) Workshop series. RISE workshops bring together innovators in medical product development, rare disease research, patient advocacy, and regulatory science to discuss challenges in the development of medical products for rare diseases that are common to multiple rare diseases or a class of diseases and for which evolving science offers innovative solutions.

Learn more about the Rare Disease Innovation Hub.

Office of Orphan Products Development (OOPD)

OOPD administers programs including Orphan Drug Designation, Rare Pediatric Disease Designation, and Humanitarian Use Device Designation. OOPD also administers grants for research to advance rare disease medical product development.

Learn more about the Office of Orphan Products Development.

Get Involved: Patient and Caregiver Engagement

Patients and caregivers can play an important role in helping CDRH better understand the experiences, needs, and priorities of people living with rare diseases. CDRH offers opportunities and resources to help patients and caregivers share their perspectives and learn how they can contribute throughout the medical device life cycle.

Patient and Caregiver Connection

The Patient and Caregiver Connection provides opportunities for patients and caregivers to share their experiences and perspectives living with medical conditions and using medical devices with CDRH.

Patient Education Courses

CDRH’s Patient Education Courses help patients, caregivers, patient organizations learn more about medical devices and the role patients can play as advisors throughout the medical device life cycle. The courses also provide information about opportunities to engage with the FDA and medical device developers.

Relevant Links:

CDRH Patient Engagement Courses | FDA
CDRH Patient Education Program Course Video: Patients as Advisors in Medical Device Clinical Studies | FDA

Collaboration Across the FDA

Collaboration across the FDA is important to advance the development and timely marketing authorization of safe and effective medical products for people with rare diseases. CDRH works with programs and experts across the FDA to share knowledge, coordinate efforts, and address cross-cutting challenges in rare disease product development.

Collaborators across the FDA include:

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