BEUDAMED
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    CHROMATOGRAPHY CLINICAL USE 75JQR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MINXRAY P300 X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED

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

    TAPER SLEEVE ADAPTER 12/14 +2

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code JDI·July 15, 2015

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·January 15, 2013

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 4, 2014

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    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