BEUDAMED
    5 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSUREFIX(R)

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OMNISCIENCE CARDIAC VALVE PROSTHESIS

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·COSEAL SURGICAL SEALANT

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOK·April 30, 2025

    ATELLICA IM ALPHA FETOPROTEIN (AFP)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LOK·December 4, 2025