Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp™ Unidirectional Ablation Catheter, Small Curve, DiamondTemp™ Unidirectional Ablation Catheter, Large Curve,

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY FOR URINARY CONTROL

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·SurVeil Drug-Coated Balloon

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBC EIA

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEMS

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERCEED (TC7) ABSORBABLE ADHESION BARRIER

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·BARD FLAIR ENDOVASCULAR STENT GRAFT

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact Spine Sealant System 3mL & 5mL

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ANGIOSCULPT PTCA SCORING BALLOON CATHETER

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM