BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    MPS2 Myocardial Protection System Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFE+CEL OR LIFECEL BATTERY

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 23, 2011

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 17, 2013

    VERSAFITCUP CC TRIO ACETABULAR SHELL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code LZO·August 19, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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