BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 25, 2012

    TELEMETRY WAND MODEL

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    J-CATH(TM)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 12, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 12, 2024

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 19, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 25, 2010

    IMPACT 754 PORTABLE VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·IMPACT INSTRUMENTATION, INC.·Product code BTL·December 17, 2012