BEUDAMED
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    truFreeze System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    K152468

    FDA UDI
    Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100479·TANNA-LIEBERMAN EYE SPECULUM WITH POSTS

    ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OR SPECIFIC BIG CASE BACK TABLE COVER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 7, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 24, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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