BEUDAMED
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    GUTTA PERCHA

    FDA 510(k)
    FDA Class 1 ·Dental

    PEDIATRIC URINE COLLECTOR

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

    DOCUMENT LINEARITY TEST STANDARDS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ATTAIN ABILITY STRAIGHT

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 10, 2014

    BASAL/BOLUS INFUSOR 2ML X 2ML6 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·October 10, 2010

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 10, 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