BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    ADJUSTABLE HEAD & FACE HOLDER

    FDA 510(k)
    FDA Class 2 ·Radiology

    K2M COCR ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    SIGNATURE GOLD

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code FRN·September 26, 2012

    UNKOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 10, 2010

    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.

    FDA Recall
    Terminated ·Fisher & Paykel Healthcare, Ltd.·Product code BZD·April 22, 2013

    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.

    FDA Recall
    Terminated ·Fisher & Paykel Healthcare, Ltd.·Product code BZO·November 19, 2012