BEUDAMED
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    SYNTHES CERCLAGE POSITIONING PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERIFUSE AMBULATORY PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Laparoscope Lens Shield Device (LENS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NOTINGHM SHLDR HUM HEAD 48X17 OFFSET

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWS·January 19, 2016

    ALARIS® PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·March 14, 2016

    GEL FOAM CUSHION

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, INC.·Product code KNN·March 1, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·February 4, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·August 8, 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