BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    CMV TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIOPSY FORCEPS W/NEEDLE M.R. ASSOC.

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    CXD II

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code KDJ·August 16, 2010

    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