Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY/SOLUS/PARAGON III/PHOENIX III/SYNCHRONY II,III/ADDVENT TEMPO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL MECHANICAL HEART VALVE

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® ReSTOR Apodized Diffractive Optic Posterior Chamber IOL

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 601

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 411

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL IMPLANTABLE COLLAMER LENSES

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Urinary)

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

FDA Pre-Market Approval

FDA Class 3 ·CURRENT RF AND PROMOTE RF FAMILY OF DEVICES