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

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    HOWMEDICA SENTRY S TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCESS(R) FREE T4 ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COULTER MH015 (DIFFERENTIAL CELL COUNTER)

    FDA 510(k)
    FDA Class 2 ·Hematology

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 23, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 30, 2013

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 3, 2010

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020