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

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    MISTY BEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198550·AK3 Ultra Insert Trial Size 2, 18mm

    Custom Legacy and Custom InterActive Titanium Abutments

    FDA 510(k)
    FDA Class 2 ·Dental

    FLEXICARE BREATHING FILTERS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PULSE GEN MODEL 105

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·May 6, 2014

    EX-PRESS MINI GLAUCOMA SHUNT

    FDA Adverse Event
    Injury ·OPTONOL, LTD·Product code KYF·October 12, 2012

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 22, 2015

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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