Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REFLUX MANAGEMENT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·ReVision Optics Raindrop Near Vision Inlay

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN/VERISYSE PHAKIC IOL

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

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE DEVICES & PROMOTE ACCEL DEVICES

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE IMPLANTABLE MINIATURE TELESCOPE

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

LM-150HT LIGHT SOURCE

FDA 510(k)

FDA Class 3 ·Unknown

GASTROTEC

FDA 510(k)

FDA Class 3 ·Unknown