BEUDAMED
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    EUROPHILIC SLIPPERY COATED FOLEY CATHETER

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

    Forceps

    FDA UDI
    KOROS U.S.A., INC.·10840199539908·Cushing Wire Forceps Tungsten Carbide Jaws Deli...

    ArteVu

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENLON PPV VAPORIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016

    UNKNOWN DEPUY ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·February 5, 2013

    IAB: 8 FR - 30 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·December 3, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·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