BEUDAMED
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    ERBOTOM ICC 350

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SWANSON

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420198709·Titanium Great Toe Trial

    i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BEED 2,5, BEED 3,8

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 31, 2012

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·December 10, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code BRZ·July 14, 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