BEUDAMED
    3 results · 12ms · Sources: EU EUDAMED, US FDA

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    VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. The device is indicated for use in sealing the femoral arterial puncture site.

    FDA Recall
    Terminated ·Datascope Collagen Products Division·Product code MGB·July 28, 2003

    Ross 22 FR Magna-Port Gastrostomy Tube, Item #51366.

    FDA Recall
    Terminated ·Ross Products Division, Abbott Laboratories·Product code KNT·November 14, 2003

    The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·September 14, 2016