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

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    FDA 510(k)
    FDA Class 1 ·Dental

    Javelin Tailor's Bunion Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·November 6, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·July 19, 2011

    SM104 M-SERIES W/5TH WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 18, 2013

    ACCOLADE DR SL MRI (Model L311)

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