BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    HELENA FACTOR XI DEFICIENT SUBSTRATE

    FDA 510(k)
    FDA Class 2 ·Hematology

    QUICKSCAN HOLTER II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2014

    NONE

    FDA Adverse Event
    Other ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWA·October 9, 2012

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2010

    PROPONENT DR SL (Model L201)

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