BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    Intracept Intraosseous Nerve Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    BOMEDENT Apex locator, WISMY Apex locator

    FDA 510(k)
    FDA Unclassified ·Unknown

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    SIGN I. M. NAIL

    FDA Adverse Event
    Injury ·SURGICAL IMPLANT GENERATION NETWORK (SIGN)·Product code HSB·September 7, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    ACCOLADE DR SL MRI (Model L311)

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