MODEL 366-13 ADAPTAID STEP DOWN ADAPTER

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS

FDA 510(k)

FDA Class 3 ·Orthopedic

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

FDA 510(k)

FDA Class 3 ·Orthopedic

MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Systems

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON A & LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic

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 ·DURASOFT(R) 3 FOR EXT WEAR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass Ultra System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CERVICAL STIM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM