BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CENATOR TOTAL HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RASCAL II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOTAL ASR ACET IMP SIZE 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·January 30, 2013

    POLESTAR INTEGRATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·December 3, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 15, 2014

    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