Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HEALTHTRONICS OSSATRON

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE-FILLED BREAST IMPLANTS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·INSITE HER-2/NEU KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval

FDA Class 3 ·MELAFIND

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY CARDIAC ABLATION SYSTEM