BEUDAMED
    2,655 results · 17ms · 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 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SJM PACEMAKERS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SJM ICDS

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

    FDA Pre-Market Approval
    FDA Class 3 ·SJM CRTDS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SJM ICDS

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SJM LEADS

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SJM LEADS

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·SJM PACEMAKERS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·SJM MRI Activator

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM PYROLYTIC CARBON

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM PYROLYTIC CARBON

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

    FDA Pre-Market Approval
    FDA Class 3 ·SJM CRT-DS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·SJM MASTERS VALVED GRAFT