Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER 4MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·ETHICON OMNEX SURGICAL SEALANT

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL SNoW Absorbable Hemostat

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE /HALL EASY FIT

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE AND D-STAT FLOWABLE HEMOSTAT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS CATHETER (8MM)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER