BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SERAQUEST ANTI-THYROID PEROXIDASE (TPO)

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,

    FDA 510(k)
    FDA Class 2 ·Immunology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 22, 2013

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·December 9, 2010

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 9, 2014

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Enforcement
    Class I ·Terminated·BioMedical Equipment Service Co (BMES)·August 18, 2021