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

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    CHLORIDE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

    FDA 510(k)
    FDA Class 2 ·Hematology

    BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 13, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 13, 2012

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·October 18, 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