BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ARC 400

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    STIMPOD MODEL NMS-400 NERVE STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIGITAL RADIOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    OPTISENSE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·July 13, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·December 10, 2024

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 5, 2023

    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