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

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    FDA 510(k)
    FDA Class 2 ·Radiology

    FIBERNET EMBOLIC PROTECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED M-IV MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN TRABECULAR METAL REVERSE SHOULDER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HSD·August 10, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 8, 2013

    MESHGRAFT II COMPLETE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL, INC.·Product code FZW·January 12, 2016

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021