BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    COBE STOPCOCK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INREACH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    NAVIO™ Surgical System (NAVIO system)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 12, 2007

    ACCOLADE SR SL MRI (Model L310)

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