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U.S. Food and Drug Administration
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  2. Combination Products
  3. Jurisdictional Information
  4. RFD Jurisdictional Decisions
  5. Capsular Decisions - Products Assigned to CDRH
  1. RFD Jurisdictional Decisions

Capsular Decisions - Products Assigned to CDRH

A. Devices

  • Agent used to prepare skin for adhesion of bandages
  • Gel used as barrier to prevent surgical adhesions
  • Hyaluronic acid viscosupplement for treatment of arthritis pain
  • Absorbable barrier to prevent surgical adhesions
  • Polysaccharide intended to act as protective barrier
  • Radiation-containing glass beads for cancer treatment
  • Device to hyperpolarize gas for use during magnetic resonance imaging
  • Extracorporeal lipid removal system
  • Physical barrier for dental use
  • Oral wound dressing providing physical barrier
  • Device to provide controlled hypoxia
  • Needle-free injector for administration of a biological product
  • Needle-free injector for administration of a drug
  • Processed animal connective tissue for use in orthopedic surgery
  • LAL-based in vitro test to aid in the diagnosis of fungal infections
  • Device for disinfection of harvested bone
  • Collagen/oxidized regenerated cellulose wound dressing
  • Intraperitoneal drug delivery system
  • Device that controls delivery of medication from implanted delivery system
  • Human allograft demineralized bone matrix with additives to make putty or paste
  • Animal collagen bone void filler
  • Medical maggots for wound treatment
  • Solution for rinsing preserved organs prior to reimplantation
  • Device to produce sterile water for injection
  • Laser-activated surgical tissue welding tube
  • Vitreous visualization agent
  • Ozone production/delivery device for dental use
  • Device that produces oxygenated water for topical oxygen therapy
  • Device for pulsatile delivery of therapeutic solutions
  • Kit for intestinal permeability testing
  • Peak flow meter accessory for metered dose inhalers
  • Bone and collagen allograft for bone grafting
  • Device to monitor use of metered dose inhalers
  • In vitro diagnostic test for hepatitis (for patient management)
  • Immunodiagnostic assay for hepatitis (for individual patient use)
  • Branched DNA technology-based quantification assay for Hepatitis C (for patient management)
  • Branched DNA technology-based quantification assay for Hepatitis B (for patient management)
  • Injectable polymer for urological use
  • Sterile water for inhalation therapy
  • Sterile water with saline for inhalation therapy
  • Dressing that binds enzymes from wounds
  • Adjunct to a PAP machine to treat breathing disorder
  • Wound cleansing/debriding product
  • Device that provides humidified hyperbaric oxygen for wound management
  • Device for mixing and delivery of fibrin sealants
  • Dual syringe applicator for delivery of fibrin sealants
  • Reusable autoinjector for use with specified prefilled syringe cartridges
  • Animal tissue-derived scaffold for ligament replacement
  • Surfactant-based lubricant to act as adhesion barrier in pelvic and abdominal surgery
  • Heating/drug delivery device for cancer treatment
  • Device and inhaled gas mixture to measure cardiopulmonary function
  • Topical paste for wound covering
  • Accessories to blood/fluid warming device
  • Polymeric sealant to seal air leaks in the lung
  • Computer-based system to help monitor and manage Parkinson’s Disease
  • More than minimally manipulated structural human tissue for use in vascular procedures
  • Device with tracer for evaluation of lung function

B. Combination Products with Device Primary Mode of Action

  • Breath collection/analysis devices and drug for H. pylori diagnosis
  • Laser and photosensitizing agent for antimicrobial use
  • Dialysate with drug component
  • Heparin-coated cardiovascular stent
  • Drug-eluting cardiovascular stent
  • Radiolabeled drug-eluting cardiovascular stent
  • Vascular graft with antibiotic
  • Dental floss with fluoride
  • Dental floss with antimicrobial agent
  • Dental filling material with antimicrobial agent
  • Dental sealant with antimicrobial agent
  • Dental cement with antimicrobial agent
  • Periodontal barrier with antibiotic
  • Adhesive bandage with antibiotic
  • Physical/chemical embolization product
  • Cardiovascular stent and injectable drug
  • Orthopedic prosthesis coated with growth factor
  • Coronary stent coated with biological product
  • Dental prophylaxis paste with fluoride and antimicrobial agent
  • Dental implant coated with autologous cells
  • Dental implant and synthetic peptide used to promote its integration
  • Wound dressing impregnated with drug ointment
  • Occlusive wound dressing with biologic component
  • Catheter lock flush solution with antimicrobial and anticoagulant agents
  • Dental wax with anesthetic for discomfort associated with orthodontic procedures
  • Dental restorative material with fluoride
  • Breath collection/analysis devices and drug for diagnosis of lactose maldigestion
  • Breath collection/analysis devices and drug for diagnosis of gastric emptying disorders
  • Breath collection/analysis devices and drug to monitor enzyme activity
  • Breath test kit and drug for use during pharmacological research
  • Breath collection/analysis devices and drug for diagnosis of intestinal bacterial overgrowth
  • Breath test and drug for assessment of small intestinal function
  • Blood test and drug for detection of H. pylori in the stomach
  • Embolization device coated with a radiopharmaceutical drug
  • Root canal cleanser with antimicrobial agent
  • Device with enzyme mimic for orthopedic use
  • Bone void filler with antibiotic
  • Menstrual tampon with drug to neutralize pH within the tampon
  • Fluorescent imaging system for use during cardiac surgery
  • Tubing with drug to reduce discomfort during placement
  • Device and lithium chloride indicator dilution to monitor cardiac output
  • Device for delivery and filtration of chemotherapeutic agents to organs
  • Device and filtration system to administer chemotherapy to limbs
  • Polymer-astringent granules for wound/laceration management
  • Laser and photosensitizing agent for dental use
  • Non-occlusive wound dressing with drug
  • Wound dressing with analgesic
  • Wound dressing with antimicrobial agent
  • Bone void filler with blood component to act as matrix and enhance handling properties
  • Vascular graft with drug-eluting mesh to maintain graft patency
  • Breath test kit and drug to measure liver function
  • Scaffold/matrix for wound treatment
  • Device and soluble intravenous gases to evaluate pulmonary function
  • Chemiluminescent light and dye for oral lesion marking
  • Collagen-thrombin hemostatic agent
  • Gelatin granules-thrombin hemostatic agent
  • Breath test kit and drug for diagnosis of insulin resistance
  • Cryotherapy device and salicylic acid for wart removal
  • Central venous catheter with antimicrobial coating
  • Therapeutic ultrasound device and gas microspheres for thrombolytic therapy
  • Surgical mesh with anesthetic coating
  • Scented respiratory device
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