Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVE LIGHT EX500 LASER SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EXCIMED(TM) UV200LA LASER SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Multi-Piece Posterior Chamber IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon B Soft Contact Lenses for Daily and Extended Wear

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Perfluoron

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval

FDA Class 3 ·ENUCLENE(R) OPHTHALMIC SOLUTION

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Aspheric UV Absorbing ReSTOR Toric IOL +2.5 and +3.0

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR POSTERIOR CHAMBER LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim™ Dorsal Root Ganglion (DRG) IPG

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR INTRAOCULAR LENSES

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ RESTOR APODIZED + 3.0D MULTIFOCAL TORIC INTRAOCULAR LENS