4,414 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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