BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    ECHO, MODEL MM-1000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FASTRACT

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975058560·

    PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL

    FDA 510(k)
    FDA Class 1 ·Dental

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 25, 2014

    PULSAR GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·August 20, 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