BEUDAMED
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    FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DENE BRIDGE

    FDA 510(k)
    FDA Class 2 ·Dental

    basixTOUCH40 Inflation Syringe

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·January 10, 2011

    T-HANDLE DRIVER

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·July 23, 2014

    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