BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    Ultrasound Workspace (UWS 6.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    C-BOOT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRISM ZIRCONIA, ST-98

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 19, 2008

    UNIVERSAL DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·September 2, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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