BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    HUFFMAN BIOPSY UNIT

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    KANTERON DICOM STATION (KDS), MODEL 3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTEROOM(POWERED OPHTHALMIC TABLE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 13, 2014

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 18, 2010

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·December 13, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014