BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    CROWN, ACRYLIC, CORAL BRAND, PREFORMED

    FDA 510(k)
    FDA Class 1 ·Dental

    Firebow Wire Torque Assist Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VISC X-VITREOUS ASPIRATING & CUT. INSTR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 18, 2014

    ACCU-CHEK ADVANTAGE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 29, 2007

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 1, 2012

    Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, 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