BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    HSV-1 ELISA IGG, MODEL EL0910G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Radiology

    CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AFX SYSTEM

    FDA Adverse Event
    Injury ·ENDOLOGIX, INC.·Product code MIH·March 7, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 26, 2011

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    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