BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    PH/BLOOD GAS CONTROL (ABC)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TINA-QUANT D-DIMER TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    POLY-CHEM 90 TOTAL BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 13, 2010

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018