Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) System

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PMP

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·LGW

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MHY

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp™ Unidirectional Ablation Catheter, Small Curve, DiamondTemp™ Unidirectional Ablation Catheter, Large Curve,

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL FAMILY OF ABSORBABLE HEMOSTATS

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Surpass Evolve™ Flow Diverter Stent System

Glue, Surgical, Arteries

FDA Pre-Market Approval

FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Trim Change

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain