BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    BITEM LOCK, MODELS SW006, SW012

    FDA 510(k)
    FDA Class 1 ·Dental

    VAS-CATH URETERAL STENT CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LATEX PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINI MAXLOCK EXTREME

    FDA Adverse Event
    Injury ·ORTHOHELIX SURGICAL DESIGNS, INC.·Product code LXH·March 5, 2013

    THROMCAT THROMBECTOMY CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·SPECTRANETICS CORP.·Product code MCW·January 14, 2011

    HUDSON PEDIATRIC BREATHING CIRCUIT, 30"

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code BSJ·July 23, 2014

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014