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

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    ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756736268·MAJOR BREAST PACK

    SENSI TOUCH PATIENT EXAM GLOVES (VINYL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REALSEAL SE

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·June 26, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 7, 2015

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·January 4, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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