BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    A.C.I. TRACH TIE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LENSTAR, MODEL LS900

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

    FDA 510(k)
    FDA Class 2 ·Radiology

    TALENT AAA STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·July 1, 2025

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·July 1, 2025

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 19, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 22, 2010

    HI TORQUE CONNECT GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BRIVANT, LTD.·Product code DQX·December 18, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022