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

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    N5-1

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ni-Lock® Anterior Cervical Plate System

    FDA UDI
    Spine Wave, Inc.·10840642103083·Plate 54mm 3 Level

    PERIOPATCH

    FDA 510(k)
    FDA Unclassified ·Unknown

    THROMBIX 3X3 HEMOSTATIC PAD

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPRINT

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 8, 2013

    ENDEAVOR RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·June 28, 2011

    UNKNOWN DEPUY LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWB·September 5, 2008

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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