BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    Augmented Reality Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDIOVATIONS PORTABLE VIDEO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Molekule Air Mini, Molekule Air Mini +

    FDA 510(k)
    FDA Class 2 ·General Hospital

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 23, 2014

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·August 18, 2011

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·December 18, 2012

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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