Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK XL PTCA CATHETER (MONORAIL)

Light Source System, Diagnostic Endoscopic

FDA Pre-Market Approval

FDA Class 3 ·KARL STORZ D-Light C PDD System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA FAMILY OF LEADS

Surgical Kit

FDA classification

Surgical Kit

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Holding Chambers, Direct Patient Interface

FDA classification

FDA Class 2 ·Holding Chambers, Direct Patient Interface

Dvd, Bluray, Or Hd Recorder

FDA classification

FDA Not Classified ·Dvd, Bluray, Or Hd Recorder

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

FDA classification

FDA Class 2 ·Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive

Biliary Stent System For Benign Strictures

FDA classification

FDA Class 2 ·Biliary Stent System For Benign Strictures

Device, Automated Cell Locating, Bone Marrow

FDA classification

FDA Class 2 ·Device, Automated Cell Locating, Bone Marrow

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

FDA classification

FDA Class 3 ·Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR IQ IOL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NINJA FX PTCA DILATATION CATHETER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OPTISENSE MODEL 1699T/TC LEADS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM