4,414 results · 27ms · Sources: EU EUDAMED, US FDA

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·ANIMAS VIBE SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·VNS THERAPY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·SOLUS 2002,2003 & SYNCHRONY II 2022,2023 PULSE GEN

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·IsoFlex™

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Evolut R, Pro and Pro+ Systems

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MODEL 7276 GEM III AT IMPLANTABLE DEFIBRILLATOR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·INTREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC(R) 7000 VERSATRAX(R) PULSE GENERATOR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·NEUGRAFT

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval
FDA Class 3 ·ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System

System, Photopheresis, Extracorporeal

FDA Pre-Market Approval
FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEMS

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPPERED FUSION DEVICE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·B AND L 70 LIDOFILCON A CONTACT LENSE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·AUTIMA PACING SYSTEM (META DDD MODEL 1230)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis