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

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    FORMA-FAS-TEST

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SERIES 810 PLATELET ANALYZER

    FDA 510(k)
    FDA Class 2 ·Hematology

    IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TELEFLEX ISIS SUCTION ACCESSORY PACK

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTR·March 24, 2014

    ENEMA BAG

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FCE·November 7, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 9, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021