BEUDAMED
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    HEARTPORT ENDOAORTIC CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799004567·

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

    TOOB-CHEQ CARBON DIOXIDE GAS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JMB TRADING COMPANY SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·February 15, 2013

    SUMMIT DUOFIX TAP SZ6 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 6, 2011

    ENDO STITCH SOFSILK 2/0 48 BLCK DLU SU

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code KOG·May 22, 2014

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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