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

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    EBV-NA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457209737·Internal Hex "Click"

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867385795·Bending Pliers, Angled, Left

    ESIS MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIZILITE EYEWEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 13, 2010

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 19, 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