BEUDAMED
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    KOH MICRO-SUTURING INSTRUMENTS

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

    CAPTIA CMV-TA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SUGAR CHEX LINEARITY FOR THE ONE TOUCH

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PROTECTA CRT-D

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NIK·February 11, 2013

    QUICKSITE XL LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 24, 2014

    WASHER 13.0MM

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HTN·December 30, 2016

    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