BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

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

    PRESS-MATE PM-2100 VITAL SIGN MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 6, 2008

    GENESIS IPG

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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