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

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    1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577627·CoRoent Ant TLIF PEEK, 14x13x32mm 8°

    SPINDLE FOR EVOLUTION

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 27, 2020

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·18100013401463·SINGLE INSTRUMENT

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·10840200301463·SINGLE INSTRUMENT

    MICROFLO-SAFE SCALP VEIN SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 27, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 29, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2015

    SPINDLE FOR EVOLUTION

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·April 4, 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