System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTION SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis for use at One or Two Levels

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20) AND SYNVISC-ONE (HYLAN G-F 20)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER RPM CARDIAC ABLATION CATHETERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EZE-FIT(TM)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE TX CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 670G System