BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DENTURE PRODUCT X

    FDA 510(k)
    FDA Class 1 ·Dental

    COMBO 36

    FDA 510(k)
    FDA Class 1 ·General Hospital

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·January 28, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·December 9, 2010

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 24, 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