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

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    OPUS HLH CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801

    FDA 510(k)
    FDA Class 2 ·Hematology

    InTice™-C Porous Ti Cervical Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2520274-2013-10508

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MNI·February 19, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·January 18, 2011

    IS-1 BI LEAD TO IS-1 BI IPG - PERMANENT LEAD EXTENSION KIT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTD·August 1, 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