BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE PENILE BLOOD PRESSURE CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRACROWN 75 ALLOY

    FDA 510(k)
    FDA Class 2 ·Dental

    AGAR 8000 TENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code FOZ·March 11, 2014

    GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code HCG·December 20, 2010

    PRIME ZOOM STRETCHER, ELECTRIC

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 28, 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