BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    PHENYTION EIA TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ABL80 SC80

    FDA UDI
    Radiometer Medical ApS·05700699457257·SC80 50/30 Full-OX, noGlu, noQC3

    CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE

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

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 4, 2016

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 9, 2015

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 15, 2013

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 6, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2014

    FUSION QUATTRO EXTRACTION BALLOON

    FDA Adverse Event
    Malfunction ·WISLON-COOK MEDICAL INC.·Product code GCA·July 23, 2015

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    5.0MM TI SIDE-OPENING SCREW 40MM

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    TI NUT 11MM WIDTH ACROSS FLATS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 19, 2012

    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