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

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    UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APTEK ULTRASOUND PROCEDURE TRAY

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 8, 2010

    HUMAPEN MEMOIR

    FDA Adverse Event
    Malfunction ·ELI LILLY AND COMPANY·Product code NSC·December 10, 2012

    RX PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·November 19, 2021

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012