Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/SENSIA/VERSA/RELIA

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·PROCOL VASCULAR BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND CALIBRATOR

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS VASCULAR STENT

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Everolimus-Eluting Platinum Chromium Coronary Stent Systems

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·GORE Carotid Stent

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR/SR IPG

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·ISOMED INFUSION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Vitatron Brilliant S+ VDD Lead

Material, Dressing, Surgical, Polylactic Acid

FDA Pre-Market Approval

FDA Class 3 ·COLLACOTE,COLLATAPE,COLLAPLUG ABSORBABLE COLLAGEN WOUND GRESSING FOR DENTAL SURGERY

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM