BEUDAMED
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    DILATION CATHETER, BALLOON

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

    NUPRO®

    FDA UDI
    Dentsply Professional·D0039650671·NUPRO REVOLV SLIM DPA SOFT

    DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·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