BEUDAMED
    10,000 results · 48ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI IPG

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filter

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·BSC Wolverine Coronary Cutting Balloon

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, PERIMOUNT Magna Pericardial Aortic BIoprosthesis wi

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESES/ THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX T

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ST. JUDE MEDICAL MECHANICAL HEART VALVE

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER & CABLE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·GEM II/MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, 4194, LEFT VENTRICULAR PACING LEAD, 4193

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM