BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    TERUMO SENSIBEAD(TM) EIA HLH KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WHITE BLOOD CELLS HUMAN TAND B

    FDA 510(k)
    FDA Class 2 ·Hematology

    MULTIANALYTE CONTROLS-ALL KINDS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 10, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 10, 2012

    FORTIFY DR, U1.6 DF1 ID

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)·Product code LWS·June 23, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015