BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    CASSETTE EMBOSSEER

    FDA 510(k)
    FDA Class 1 ·Pathology

    PANA SPRAY Plus

    FDA 510(k)
    FDA Class 1 ·Dental

    DEN TEK NIGHTGUARD

    FDA 510(k)
    FDA Unclassified ·Unknown

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 10, 2014

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·December 10, 2012

    MEDSTREAM PUMP 40 ML

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code LKK·June 23, 2015

    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