BEUDAMED
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    C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POS COMBO PANEL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CONTACT-K APTT REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 19, 2014

    ECHELON*FLEX60 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·October 27, 2010

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·December 21, 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