BEUDAMED
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    CHAD TOTAL O2 DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704294293·

    DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reusable Blood Pressure Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROLIFT +M PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·February 21, 2013

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·January 27, 2011

    ANEURX

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 31, 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