BEUDAMED
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    MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.

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

    cobas CT/NG for use on cobas 6800/8800 systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVANCE EMIT CAD DISOPYRAMIDE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTRAVIA CONTAINER 150ML

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KPE·May 29, 2014

    GLV SURG ESTEEM NEU-THERA PF SYN SZ 7.0

    FDA Adverse Event
    Injury ·CARDINAL HEALTH·Product code KGO·October 19, 2010

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 14, 2012

    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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013