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

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    encevis

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100783·FLIERINGA FIXATION RING 17MM

    AVIAFIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JULIET OL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENUMBRA COIL 400

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·November 29, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 14, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 16, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2011

    RING TRANSJUGULAR INTRAHEPATIC ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 15, 2019

    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