BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    TAG

    FDA UDI
    Smith & Nephew, Inc.·00885556601181·MTO TAG ARTHRSC DRILL GUIDE W/10MM SLOTS

    CEROX, MODEL 321OF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASSAYED QCS 1,2, CAT. NOS. 970200, 970500

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code DHA·June 27, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·December 12, 2012

    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    FDA Enforcement
    Class I ·Ongoing·Zyno Medical LLC·June 18, 2025