BEUDAMED
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    Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLICK HOLTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 2, 2011

    QUANTA SYSTEM

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    S-ROM HEAD FEMORAL COCR 32+9

    FDA Adverse Event
    Injury ·DEPUY IRELAND ¿ REG. # 9616671·Product code JDG·November 6, 2014

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025