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

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    NOVA LITE ENDOMYSIAL

    FDA 510(k)
    FDA Class 2 ·Immunology

    PE/Cyanine7 anti-human CD38

    FDA UDI
    BIOLEGEND, INC.·00810034701947·URL: https://www.biolegend.com/en-us/products/p...

    WAKO(TM) AUTOKIT TOTAL PROTEIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTONOM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 25, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

    LAMITRODE 88 LEAD KIT, 60 CM LENGTH

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·February 2, 2011

    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