BEUDAMED
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    CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Scio Four, Oxi plus

    FDA UDI
    Drägerwerk AG & Co. KGaA·04048675429302·

    Rongeur

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108482·KERRISON RONGEUR SIZE 1

    VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·June 12, 2025

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 17, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 16, 2010

    UNKNOWN DEPUY FEMORAL HEAD (ASPHERE M-SPEC 36MM +1.5)

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KXA·December 13, 2012

    INTELLIVUE MULTI-MEASUREMENT MODULE X3

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·February 11, 2026

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022