Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·DUOVISC VISCOELASTIC SYSTEM & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

Ultrasound, Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Multi-Piece Posterior Chamber IOL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Scandinavian Total Ankle Replacement (STAR Ankle)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·COBRA PzF NanoCoated Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof® Posterior Chamber Intraocular Lens

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation Multilead Trial Cable (DBS MLTC)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·INTRAOCULAR LENS MODELS C118;C119;C138 AND C139

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM PULSE GENERATORS

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 ·ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System