BEUDAMED
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    DELPORE SKIN CLOSURE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Disposable Temporary Pacing Cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·February 9, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Other ·INSULET CORPORATION·Product code LZG·January 4, 2011

    PINNACLE MTL INS NEUT44IDX62OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·July 23, 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