BEUDAMED
    13 results · 61ms · Sources: EU EUDAMED, US FDA

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    GUIDEWIRE TECHNOLOGIES, INC.

    FDA registration
    GUIDEWIRE TECHNOLOGIES, INC.·2 products·🇺🇸 United States

    HEMOLUNG RAS

    FDA Adverse Event
    Death ·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 18, 2023

    CARDIO-PAK

    FDA Adverse Event
    Malfunction ·GUIDEWIRES TECHNOLOGIES, INC.·Product code DQX·May 12, 1994

    HEMOLUNG RAS

    FDA Adverse Event
    Malfunction ·ALUNG TECHNOLOGIES, INC.·Product code QLN·January 18, 2023

    HEMOLUNG RAS

    FDA Adverse Event
    Malfunction ·ALUNG TECHNOLOGIES, INC.·Product code DQR·January 18, 2023

    NYKANEN RADIOFREQUENCY WIRE KIT

    FDA Adverse Event
    Malfunction ·BAYLIS MEDICAL COMPANY INC.·Product code GEI·November 16, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 4, 2019

    K-WIRE 1.1MM, SMOOTH, SINGLE TROCAR

    FDA Adverse Event
    Malfunction ·OSTEOCENTRIC TECHNOLOGIES, INC.·Product code HTY·December 7, 2023

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR·Product code OUT·February 14, 2019

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    FDA Adverse Event
    Injury ·NORTHGATE TECHNOLOGIES INC.·Product code FFK·June 14, 2022

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·July 16, 2018

    Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    FDA Adverse Event
    Injury ·NORTHGATE TECHNOLOGIES, INC·Product code FFK·September 29, 2022