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

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    ECVUE MAPPING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISTAL RADIO-ULNAR JOINT IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACUITY

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWP·October 3, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 31, 2013

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2011

    BD VIPER¿ LT SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code OOI·August 14, 2023

    PIPELINE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·August 25, 2023

    PIPELINE FLEX EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·August 25, 2023

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    CASH 14 PLAT COIL 4MMX6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    GALAXY G3 MINI 3MM X 6CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·May 18, 2022

    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