BEUDAMED
    6,530 results · 25ms · 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 ·LIAISON® XL Murex HBsAg (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) and LIAISON® XL Murex HBsAg Confirmat

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

    FDA Pre-Market Approval
    FDA Class 3 ·ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    FDA Pre-Market Approval
    FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    FDA Pre-Market Approval
    FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    Leadless Cardiac Resynchronization Therapy (Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·RF MARINR/NTC/5F RF MARINR/RF CONDUCTR/RF ENHANCR II ABLATION/RF CONTACTR/CONDUCTR SELF-REF/ATAKR II

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INCEPTA, ENERGEN, PUNCTUA AND COGNIS CRT-D

    Analyzer, Data, Obstetric

    FDA Pre-Market Approval
    FDA Class 3 ·STAN S31 FETAL HEART MONITOR

    Analyzer, Data, Obstetric

    FDA Pre-Market Approval
    FDA Class 3 ·NEOVENTA'S STAN S31 FETAL HEART MONITOR