BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    HELENA COLOSCREEN SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    CADENCE, MODELS 2001 AND 2002

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NUVIS ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·December 23, 2019

    ECHELON*FLEX60 LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 30, 2014

    3.5MM TI LCP® PLATE 8 HOLES 111MM

    FDA Adverse Event
    Injury ·SYNTHES·Product code HRS·November 20, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 12, 2015

    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