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

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    ACA CREATINE KINASE ISOENZYMES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127307·Apex Revision Knee System-Revision Femur Box Cu...

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690194958·Apex Revision Knee System-Revision Femur Box Cu...

    ANALYZER, SENTORR BLOOD GAS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents

    FDA 510(k)
    FDA Class 2 ·Immunology

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE·Product code KDJ·May 5, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    CANCELLOUS BONE SCREW 6.5X15MM (QTY 3)

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code HRS·August 5, 2010

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024