BEUDAMED
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    PROPEL Device

    FDA 510(k)
    FDA Class 2 ·Dental

    DC-6 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEMOSIL PROTEIN S ACTIVITY ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 11, 2013

    COMET XL40

    FDA Adverse Event
    Injury ·GRASS TECHNOLOGIES·Product code GWQ·July 15, 2011

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN FORMERLY TYCO·Product code DQA·September 17, 2008

    Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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