BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    INTRAUTERINE CATHETER AND INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COUNTER OTC TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UNKNOWN TSL

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORI·Product code FTL·December 10, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 14, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 31, 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