Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Excimer Laser System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AIR OPTIX plus HydraGlyde / AIR OPTIX plus HydraGlyde for Astigmatism / AIR OPTIX plus HydraGlyde Multifocal / AIR OPTIX

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Provisc Ophthalmic Viscosurgical Devices

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(TM)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim family of SCS IPGs

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 38XE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SlimTip DRG Trial Lead Kit, 50cm & 90cm / SlimTip DRG Implant Lead Kit, 50cm & 90cm / DRG Lead Extension Kit.

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE PIECE POSTERIOR CHAMBER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Implantable Pulse Generator

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Brio Neurostimulation System