BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    Life Spine Cannulated Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490542609·CAGE ADAPTER BASE CASE

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar

    S-LIFT®

    FDA UDI
    SPINEFRONTIER, INC.·00190361038634·6MM TRIAL S-LIFT

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120519·Guidewire 1.2x150mm Sgl Trocar

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE

    STELLATE GRIDVIEW

    FDA 510(k)
    FDA Class 2 ·Neurology

    GE LOGIQ TWIN

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·July 31, 2015

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·May 30, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

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    FDA Adverse Event
    Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FPA·August 19, 2008

    DOUBLE MOBILITY HC LINER 28/DMF

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 1, 2016

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024