BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    MODIFIED USE OF TRIANGLE BANDAGE STERILE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228741611·GC Initial™ Ti Gingival Universal Refill GM-23...

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556704278·GC Initial™ Ti Gingival Universal Refill GM-23...

    PTCA GUIDING CATHER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIVERSAL PAC

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655·Product code JWH·June 16, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 15, 2010

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 14, 2012

    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