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

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    EMIT QST TOBRAMYCIN CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FACET FIXX

    FDA 510(k)
    FDA Unclassified ·Unknown

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014

    ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER, 75MM LENGTH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·December 20, 2007

    PULSAR II GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC ADVANCED ENERGY, LLC·Product code MUL·November 14, 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