BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION

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

    IMALUX OCT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·June 8, 2021

    8010042-2008-00160

    FDA Adverse Event
    Malfunction ·Product code CBK·October 2, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 3, 2011

    SROM STM STD 36+12L 15X20

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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