BEUDAMED
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    NUNA LUX (NUNL528)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK

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

    ACCU-CHEK AVIVA PLUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HOVEROUND CORPORATION

    FDA Adverse Event
    Injury ·HOVEROUND CORP.·Product code ITI·November 13, 2008

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 4, 2011

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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