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    DRI OCT Triton

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Ophthalmic Ring

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL

    BILLY BOY MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYMBIQ DUAL CHANNEL INFUSER

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FRN·June 13, 2014

    PRIME CARE (R) TRANSCEND PERIMETER MATTRESS

    FDA Adverse Event
    Malfunction ·PRIMUS MEDICAL LLC·Product code IKY·October 10, 2014

    CURLIN INFUSION IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·May 30, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 23, 2011

    Allura Xper FD20/20; System Code: 722038;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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