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

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    RHEUMELISA II HISTONE ANTIBODY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AEQUALIS SHOULDER FRACTURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·January 23, 2013

    GLENOID, PE WITH PEG, LARGE

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code KWS·December 20, 2010

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 14, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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