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

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    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015