BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    MCAS (MODULAR CLIP APPLIER SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MANAN HUBER STYLE INFUSION NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·February 28, 2013

    CASPAR

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code LXH·January 28, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·August 6, 2014

    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