BEUDAMED
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    SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hope&Her Vaginal Dilators

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PULPDENT SEMI-GEL ETCH

    FDA 510(k)
    FDA Class 2 ·Dental

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·June 2, 2014

    NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 4 -

    FDA Adverse Event
    Injury ·ZIMMER TMT·Product code JWH·January 11, 2013

    CAPSURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 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