Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

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

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Monovisc High Molecular Weight Hyaluronan

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP and Impella RP with SmartAssist

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM