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

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    TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANDA PEARL, ULTRAWYTE, PEARL

    FDA 510(k)
    FDA Class 1 ·Dental

    CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·January 18, 2013

    SIGMA 300 D

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·January 14, 2014

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015