Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Valve Registry (ZEVR)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CATHETERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·AXSYM CORE-M

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis product family

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON -TB GOLD

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·Sharps Terminator

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGG ENZYME IMMUNOASSAY

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX (R) CERAMIC TOTAL HIP SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE(R) CARDIAC ABLATION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA)