Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINAL-STIM(R) MODEL 8212C

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Intraocular Lens

FDA Pre-Market Approval

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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim SCS Neurostimulation System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA Multi-Piece Posterior Chamber Intraocular Lens

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MULTI-PIECE PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser System

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·Silikon 1000

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·LASER WELDING/RHAR,PMMA HAPTICS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 58LE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM(R)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CRYSTAL BLUE OPAQUE DURASOFT 3 HYDROPHILIC LENS

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM