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    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONT BLANC PEDICLE SCREW SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPROCESSED ELECTROSURGICAL ELECTRODE

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

    COBALT CHROME FEMORAL HEAD SZ 28 3.5MM 12/14 SHORT NECK

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JDI·December 15, 2016

    COCR HEAD SHORT NECK DIA28/-3. 5 MM 12/14

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·May 10, 2016

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 17, 2017

    COBALT CHROME FEMORAL HEAD

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code JDI·August 31, 2017

    PLUM A+ DRIVER ED 2

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 14, 2014

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·November 24, 2010

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·January 8, 2013

    BIOMET COBALT-CHROME FEMORAL COMPONENTS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JDI·April 7, 2017

    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