BEUDAMED
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    STERILE DENTAL ROLL

    FDA 510(k)
    FDA Class 1 ·Dental

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581270900001·A-FIT® 2. MOLAR UPR LFT SZ 09

    POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) (GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STIMULATION/DISSECTION INSTRUMENTS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 15, 2014

    TBD

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·October 31, 2012

    SUMMIT POR TAPER SZ8 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 2, 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