BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    XYLOS XCELL ANTIMICROBIAL DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 6, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    REFLEX ULTRA PTR WITH INTEGRATED CABLE

    FDA Adverse Event
    Other ·ARTHROCARE CORP.·Product code GEI·April 29, 2011

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 15, 2020

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·July 14, 2020

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015