BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICA-OF EMIT AED PRIMIDONE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OPRATEX ABDOMINAL PAD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PLUM A+ DRIVER NEW

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014

    ALTERNATING PRESSURE AIR FLOTATION MATTRESS

    FDA Adverse Event
    GRAND HEALTHCARE CO., LTD.·Product code FNM·November 14, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 13, 2010

    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