Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

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

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MR PREMOUNTED STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc® L

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

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

FDA Pre-Market Approval

FDA Class 3 ·ATLAS II+ HF CRT-D & PROMOTE CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi Open-Irrigated Ablation Catheter

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·IPure Preloaded IOL System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim System

Diagnostic Low Electric Field

FDA Pre-Market Approval

FDA Class 3 ·MarginProbe System

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO/EVO+ VISIAN® Implantable Collamer® Lenses

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Family of Implantable Pulse Generators

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit