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    SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150782·K-WIRE - SINGLE TROCAR 2.5mm DIA x 230mm

    MODIFIED LASERFLO BLOOD PERFUSION MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOUCH TALKER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN DEPUY DEVICE

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 15, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 19, 2011

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·July 29, 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