BEUDAMED
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    Aria

    FDA 510(k)
    FDA Class 2 ·Radiology

    XVAC

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NITI-S ESOPHAGEAL STENT

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·October 15, 2014

    RELIANT STENT GRAFT BALLOON CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 22, 2011

    JOURNEY II BCS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 20, 2013

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code MBI·February 3, 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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012