BEUDAMED
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    SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAPIMED DISPOSABLE SIGMOIDOSCOPE

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

    TXM Hydrophilic Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·June 12, 2014

    SROM STM ST, 36+8L NK, 18X13X160

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code MRA·October 7, 2010

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 12, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 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