10,000 results
·
46ms
·
Sources: EU EUDAMED, US FDA
Catheter, Coronary, Atherectomy
FDA Pre-Market Approval
FDA Class 3
·ROTATIONAL ATHERECTOMY SYSTEM
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SELECTED FAMILIES OF ICDS
Defibrillator, Implantable, Dual-Chamber
FDA Pre-Market Approval
FDA Class 3
·Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
Ophthalmic Sealant
FDA Pre-Market Approval
FDA Class 3
·RESURE SEALANT
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
FDA Pre-Market Approval
FDA Class 3
·QUANTIFERON- TB GOLD TEST
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS
Prosthesis, Intervertebral Disc
FDA Pre-Market Approval
FDA Class 3
·prodisc C Total Disc Replacement
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·OrganOx metra System
Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
FDA Pre-Market Approval
FDA Class 3
·PD-L1 IHC 22C3 pharmDx
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·MACROPLASTIQUE IMPLANTS
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·GENESIS NEUROSTIMULATION (IPG) SYSTEM
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Implanted Brain Stimulator For Epilepsy
FDA Pre-Market Approval
FDA Class 3
·NEUROPACE RNS SYSTEM
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·LCS TOTAL KNEE SYSTEM
Intraocular Pressure Lowering Implant
FDA Pre-Market Approval
FDA Class 3
·CyPass Micro-Stent