BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REUMAGEN ASL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    EMIT PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    AUTOSOFT XC

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 11, 2024

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPI ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·June 19, 2014

    POLIGRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·October 21, 2010

    GORE DRYSEAL SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code DYB·December 11, 2012

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

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