682 results · 21ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·Cormet Hip Resurfacing System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Brio Neurostimulation System

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Axium Neurostimulator System

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval
FDA Class 3 ·Rapid fFN for the TLiIQ System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Genesis Neurostimulation System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·enVista hydrophobic acrylic IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

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

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

FDA Pre-Market Approval
FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·SILIKON 1000

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval
FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

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

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER AND CELSIUS DS 8 MM DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval
FDA Class 3 ·OPRA™ System

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·ESSURE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM