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

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    MODEL 5000, LIQUID CHROMATOGRAPHY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    H. PYLORI QUIK CHEK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION TO INREACH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALUMINA C-TAPER HEAD 32MM/-2.5

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LZO·April 30, 2014

    ADVANCED HEALING - B

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code HWC·October 10, 2012

    EXPRESS SD BILIARY STENT SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·August 3, 2010

    Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022