BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SKYTRON MODEL 1100 AND MODEL 142

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MiniScope-Right 18mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199002900·

    ESTEMP NE

    FDA 510(k)
    FDA Class 2 ·Dental

    LAZERSMILE, LAZERWHITE

    FDA 510(k)
    FDA Class 1 ·Dental

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 5, 2014

    F6 DIALYZER FINISHED ASSY (CASE)

    FDA Adverse Event
    Malfunction ·OGDEN MFG·Product code FJI·October 25, 2010

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·December 18, 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