BEUDAMED
    152 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·BIO RAD MONOLISA ANTI-HBC IGM EIA

    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

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·OrganOx metra System

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA classification
    FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

    Lens, Intraocular, Phakic

    FDA Pre-Market Approval
    FDA Class 3 ·EVO/EVO+VISIAN Implantable Collamer Lens

    Phakic Toric Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS