BEUDAMED
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    OWENS BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER

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

    Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 23, 2013

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 10, 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