Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval

FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON -L ADHESION CONTROL IN A BARRIER GEL

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·MicroTransponder® Vivistim® Paired VNS™ System

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON-L ADHESION CONTROL IN A BARRIER GEL

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

Stimulator, Functional Neuromuscular, Scoliosis

FDA Pre-Market Approval

FDA Class 3 ·SCOLITRON(TM) STIMULATOR

Implanted Fecal Incontinence Device

FDA classification

FDA Class 3 ·Implanted Fecal Incontinence Device

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA classification

FDA Class 3 ·Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Microspheres Radionuclide

FDA classification

FDA Class 3 ·Microspheres Radionuclide

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA classification

FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Ventricular (Assist) Bypass

FDA classification

FDA Class 3 ·Ventricular (Assist) Bypass

Transcatheter Septal Occluder

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)

Mandibular Condyle Prosthesis

FDA classification

FDA Class 3 ·Mandibular Condyle Prosthesis

Device, Incontinence, Mechanical/Hydraulic

FDA classification

FDA Class 3 ·Device, Incontinence, Mechanical/Hydraulic

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer