BEUDAMED
    9 results · 33ms · Sources: EU EUDAMED, US FDA

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    OPTIPHOR-10

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340348348·SS NON-LOCKING SCREW L60MM D5MM

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340347655·SS NON-LOCKING SCREW L60MM D5MM STERILE

    Varian Head Frame

    FDA 510(k)
    FDA Class 2 ·Radiology

    STELLAR 404 MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 21, 2014

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 21, 2012

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Other ·DEXCOM, INC.·Product code MDS·September 14, 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