BEUDAMED
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    MONO-CUBE(TM)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO

    FDA 510(k)
    FDA Class 2 ·Radiology

    Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    MULTI-LINK 8

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 29, 2010

    SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·December 31, 2012

    SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures where infection by gentamicin-sensitive organisms is a potential risk.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·October 30, 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

    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