BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OPTICAL BIOMETER AL-SCAN

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STRYKER SWITCHPOINT INFINITY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 2, 2024

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008

    LUMAX 540 HF-T

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·July 22, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2013

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 26, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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