BEUDAMED
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    Biograph VK10

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRAIN PERFUSION OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNGO CT SINGLE SOURCE DUAL ENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 25, 2018

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·November 6, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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