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

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    REACH HIP COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIASAFEplusUS

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

    INFANT SLEEP BEANIE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROXIMATE PROXIMATE PLUS MD SKIN STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GDT·April 30, 1998

    ARCHITECT C4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 28, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 28, 2016

    STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HWC·January 21, 2011