BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    NIO COLOR 2MP

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPINAL CONCEPTS INC. CODA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 6, 2014

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·July 16, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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