BEUDAMED
    38 results · 26ms · Sources: EU EUDAMED, US FDA

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    Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INDIGO SYSTEM ASPIRATION CATHETER 5

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·November 21, 2016

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·February 12, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·May 29, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·January 17, 2020

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·December 7, 2018

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·January 29, 2021

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·December 10, 2020

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·June 5, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·January 25, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·January 25, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·July 28, 2020

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·July 29, 2020

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·September 11, 2020

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·September 24, 2019

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·September 11, 2020

    INDIGO SYSTEM ASPIRATION CATHETER D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 20, 2020

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·April 18, 2019

    INDIGO SYSTEM ASPIRATION CATHETER 6

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·March 15, 2017

    INDIGO SYSTEM CATD ASPIRATION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DXE·February 7, 2019