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