BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    LC ChromeFlow

    FDA 510(k)
    FDA Class 2 ·Dental

    VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AESPIRE 7900, AESPIRE VIEW

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 19, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 19, 2024

    HYLAMER 10D 48OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·November 4, 2008

    TRAUMA TRANSTAR

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·July 14, 2011

    EZ BREATHE ATOMIZER

    FDA Adverse Event
    HEALTH & LIFE (SUZHOU) CO., LTD.·Product code CCQ·July 5, 2013

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025