10,000 results
·
54ms
·
Sources: EU EUDAMED, US FDA
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·TRYTON Side Branch Stent
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator
Implantable Pulse Generator
FDA Pre-Market Approval
FDA Class 3
·OPTIMIZER Smart System
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·EASYTRAK IS-1 AND EASYTRAK LV-1 LEADS
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·TX eco Extension Cable
Ventricular (Assist) Bypass
FDA Pre-Market Approval
FDA Class 3
·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (HM II LVAS)
Prosthesis, Spinous Process Spacer/Plate
FDA Pre-Market Approval
FDA Class 3
·SUPERION INTERSPINOUS SPACER
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Senza Spinal Cord Stimulation (SCS) System
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Heart-Valve, Mechanical
FDA Pre-Market Approval
FDA Class 3
·SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY
Implantable Cardioverter Defibrillator (Non-Crt)
FDA Pre-Market Approval
FDA Class 3
·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DuraSeal Exact System
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·ARTEFILL
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Iliac Covered Stent, Arterial
FDA Pre-Market Approval
FDA Class 3
·GORE VIABAHN VBX Balloon Expandable Endoprosthesis
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Dexcom G5 Mobile Continuous Glucose Monitoring System
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol