BEUDAMED
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    Philips IntelliSite Pathology Solution 5.1

    FDA 510(k)
    FDA Class 2 ·Pathology

    Ennovate Cervical Spinal and Occiput System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Miria Skin Treatment System

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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·November 11, 2014

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 29, 2011

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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