BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Stryker 90-S Max SERFAS Energy Probe

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCANDIA-45 GAMMA CAMERA SYSTEM

    FDA 510(k)
    FDA Class 1 ·Radiology

    ACT 5DIFF RINSE

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JCB·June 15, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 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