BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Two-Step Implant System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    R4 ACERT ULTRASOUND REPORTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 8, 2019

    EA DELTA CER INSERT 36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 19, 2023

    20MM COCR RADIAL HEAD 4MM HT EXTENSION/16.0MM-STER

    FDA Adverse Event
    Injury ·SYNTHES USA PRODUCTS LLC·Product code KWI·January 19, 2018

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 28, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 21, 2013

    PHILOS II S COATED

    FDA Adverse Event
    Malfunction ·BIOTRONIK GMBH AND CO.,·Product code DXY·September 25, 2008

    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