BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    SENSI-TECT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971376·

    REPROCESSED STONE RETRIEVAL BASKETS

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

    PlayMakar Sport Muscle Stimulator, Model PRO-500

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·May 7, 2014

    ATTAIN SELECT II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DQY·October 31, 2012

    STRYKER COT - MODEL UNK

    FDA Adverse Event
    Other ·STRYKER CORP., MEDICAL DIV·Product code FPO·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