Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG family of DRG IPGs

Optoacoustic Imaging System

FDA Pre-Market Approval

FDA Class 3 ·Imagio® Breast Imaging system

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

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TORIC LENS BENCH WITH RENISHAW GAUGE ACRYSOF TORIC & ACRYSOF IQ INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF IQ TORIC INTRAOCULAR LENS (IOL)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Family of DBS IPGs

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ADAPTER

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105

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

FDA Pre-Market Approval

FDA Class 3 ·InSightec ExAblate System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEMS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Blood Pump

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS