BEUDAMED
    7 results · 24ms · Sources: EU EUDAMED, US FDA

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    SIMPLICITY PLUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PodSKAN HF Diagnostic X-ray System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHES (USA) NEW/STERIAL ORBITAL PLATES

    FDA 510(k)
    FDA Class 2 ·Dental

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    MINIARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·November 9, 2012

    CRANIAL SCREW PLUSDRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES·Product code HWC·September 9, 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