BEUDAMED
    6 results · 22ms · Sources: EU EUDAMED, US FDA

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    MONARCH™ Platform (MON-000008)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NIRO-200NX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 7, 2008

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 31, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013