10,000 results
·
57ms
·
Sources: EU EUDAMED, US FDA
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·ATTAIN STARFIX LV LEAD
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PreVue Pre-Loaded System
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA Pre-Market Approval
FDA Class 3
·Organ Care System (OCS®) Liver
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·NUVISC
Pump, Infusion, Implanted, Programmable
FDA Pre-Market Approval
FDA Class 3
·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·M-VU ALGORITHM ENGINE
Implant, Intragastric For Morbid Obesity
FDA Pre-Market Approval
FDA Class 3
·ORBERA INTRAGASTRIC BALLOON SYSTEM
Stent, Iliac
FDA Pre-Market Approval
FDA Class 3
·SMART CONTROL NITINOL STENT SYSTEM
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM215 Growth Factor Enhanced Matrix
Temporary Non-Roller Type Left Heart Support Blood Pump
FDA Pre-Market Approval
FDA Class 3
·Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
FDA Pre-Market Approval
FDA Class 3
·CERAMAX Ceramic Total Hip System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·Endurant II/IIs Stent Graft System
Stent, Superficial Femoral Artery
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QUADRIPOLAR PACING PAS (QUAD PAS)
Stimulator, Electrical, Implantable, For Incontinence
FDA Pre-Market Approval
FDA Class 3
·INTERSTIM FAMILY OF NEUROSTIMULATION LEADS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ETI-EBK PLUS