BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    DIRECT LDL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981303·anteriors; shade C3; mould BM2

    BIO-PRO UNIT

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

    TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AUTOPULSE NIMH BATTERIES

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 25, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·February 2, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 5, 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