BEUDAMED
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    DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TOX/See

    FDA UDI
    BIO-RAD LABORATORIES, INC.·00847817001352·TOX/See Drug Screen Test AMP, BAR, BZO, COC, MD...

    PACING/PSI KIT: 5 FR/6 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015

    HBO CABLE ASSEMBLY, RADIOMETER TC-02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEGACART

    FDA 510(k)

    PREMICATH 1FR PICC WITH STYLET

    FDA Adverse Event
    Malfunction ·VYGON GMBH·Product code LJS·January 31, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV·Product code FNL·December 10, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 18, 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