BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    PRE-PACK TENS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CYMUNVERA POWDER FREE GREEN NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE LINED WITH ALOE VERA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 28, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 31, 2012

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 18, 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