BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209113828·

    SEMPERFLO INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CorPath 200 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ETHILON NYLON SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAR·June 6, 2014

    HYDRATOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·October 5, 2010

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012

    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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015