BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEX-D2 Posterior Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: NUVASIVE SPHERX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PKG, WEIGHTED LIGHT HANDLE, VISUM LED

    FDA Adverse Event
    Malfunction ·STRYKER-COMMUNICATIONS·Product code FSY·March 6, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·August 11, 2015

    TI END CAP W/T40 STRDRV 15MM EXT-STER F/TI TIBIAL NAILS-EX

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code JDS·October 17, 2018

    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