BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    Arm Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CALSCOR SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 21, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE LLC·Product code NBW·November 4, 2008

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 5, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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