Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER & MICRODRIVER CORONARY STENT SYSTEMS

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MULTI-PARTITION OPERATING ENVIRONMENT (MOE), VERSION 1.0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7230 MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM,DERMA PLATFORM

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC ICD 7272

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC IPG 8040

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM MODEL 7227 CX/B/D/E

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600, 900/800, SIGMA/MEDTRONIC 350

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT 7276

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PRISMAFLEX TPE2000