BEUDAMED
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    Cryopush Cold Compression Device

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DTE

    FDA UDI
    Guilin Woodpecker Medical Instrument Co., Ltd.·06944843657769·Dental X-Ray Device

    LCP

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982157546·4.5MM LCP® CONDYLAR PLATE 18 HOLES/386MM-LEFT

    8 CHANNEL CARDIAC PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Single Use Hemoclip

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    SHUNT SENSOR SYS500

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 21, 2011

    2520274-2013-04217

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·July 12, 2013

    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