BEUDAMED
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    SUCTION APPARATUS, POWERED BY COMP. AIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Spectrum, Inc.

    FDA UDI
    SPECTRUM, INC.·00850301007273·Sterile Equipment Drape, Cordless Gama Probe, 1...

    eMurmur ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERTETRAC

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 30, 2014

    MOBICATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DYB·October 5, 2012

    LIGACLIP MCA LARGE APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDO·January 30, 2008

    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