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

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    OASIS THROMBECTOMY CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BTL-703

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    12/14 ARTICUL 44MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·February 28, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·January 13, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, 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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024