BEUDAMED
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    FLEXIBLE BIOPSY CUP FORCEPS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APEX

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

    ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FPO·December 8, 2010

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. TAIWAN·Product code INI·July 17, 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