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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVE SJM(R) MASTER SERIES

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC INTAOCULAR LENS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·INTRODUCTION CP900 SERIES RECHARGEABLE BATTERIES (A29 AND A30)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/ INTEGRITY/ VICTORY/ ZEPHYR/ACCENT FAMILY OF PACEMAKERS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ASSURITY AND ENDURITY CORE FAMILY OF PACEMAKERS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER LA-15 SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·AUGMENT BONE GRAFT

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SLS SPECTRANETICS LASER SHEATHS