BEUDAMED
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    ADVANCE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILIZATION PROCESS/BABY BLANKET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SS COMPRESSION HIP SCREW LAG SCREW

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code KTT·September 19, 2016

    BVI 6100 SCANNER

    FDA Adverse Event
    Malfunction ·VERATHON MEDICAL·Product code IYO·February 15, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 18, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014

    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