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

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    EDENTEC MODEL 2000W APNEA MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CIN AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DENTAL COTTON ROLLS

    FDA 510(k)
    FDA Class 1 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 2, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code JDI·November 26, 2012

    FRESENIUS 2008T HEMODIALYSIS SYSTEM WITH CDX

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 3, 2015

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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