BEUDAMED
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    POGO Automatic Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BI-METRIC X-SERIES HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304182806·

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024

    LANX SPINAL FIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AAP CANNULATED SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICAST COVERED STENT

    FDA Adverse Event
    Death ·ATRIUM MEDICAL CORPORATION·Product code JCT·June 14, 2013

    PATROL SET

    FDA Adverse Event
    Injury ·ABBOTT NUTRITION·Product code KNT·July 21, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 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