BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    BILE SALTS MIXTURE

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Legacy™2 Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307101604·Ø3.2 x 11.5 Platform 3.0mmD

    ZIRTOUGH

    FDA 510(k)
    FDA Class 2 ·Dental

    ENSITE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 27, 2014

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 15, 2012

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 9, 2010

    Various hysterectomy, vaginal packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    Various convenience packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022