BEUDAMED
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    THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CANMED 103

    FDA 510(k)
    FDA Class 2 ·Neurology

    STATIONARY EXERCISE BICYCLE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·June 19, 2014

    ACTIFLO INDWELLING BOWEL CATHETER SYSTEM

    FDA Adverse Event
    Injury ·HOLLISTER, INC.·Product code KNT·October 21, 2010

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·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