BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    PROFILE SERIES 29 FILES

    FDA 510(k)
    FDA Class 1 ·Dental

    Rapid

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEMOSIL D-DIMER HS 500 CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·December 17, 2010

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 21, 2012

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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