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

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    IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN

    FDA 510(k)
    FDA Class 2 ·Hematology

    3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREESTYLE

    FDA Adverse Event
    Malfunction ·Product code LFR·June 18, 2014

    LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 20, 2012

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·October 1, 2010

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024