BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    SERACULT OCCULT BLOOF TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    Perfect Fit

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377021589·Perfect Fit™ 3D REUSABLE-Disposable Kit include...

    AQUIFY LENS COMFORT DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bone VCAR (BVCAR)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·March 26, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 18, 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