BEUDAMED
    50 results · 33ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Infraredx, Inc.

    Manufacturer
    🇺🇸 United States·2 Basic UDI-DIs·2 Devices·1 Importer·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.

    Dualpro™ IVUS+NIRS Imaging Catheter

    Device
    EU MDD · Eu Md Class 3 ·Infraredx, Inc.·On the market·16 countries

    Makoto Intravascular Imaging System™

    Device
    EU MDD · Eu Md Class 2a ·Infraredx, Inc.·On the market·16 countries

    Makoto Intravascular Imaging System™

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Infraredx, Inc.·1 device

    Dualpro™ IVUS+NIRS Imaging Catheter

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Infraredx, Inc.·1 device

    TVC INSIGHT CATHETER

    FDA Adverse Event
    Injury ·INFRAREDX INC.·Product code OGZ·November 24, 2014

    TVC INSIGHT CATHETER

    FDA Adverse Event
    Injury ·INFRAREDX, INC.·Product code OGZ·November 10, 2017

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·July 12, 2024

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OBJ·December 12, 2018

    LIPISCAN CORONARY IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX INC.·Product code DQO·October 14, 2009

    DUALPRO IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·July 27, 2020

    DUALPRO IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·August 13, 2020

    DUALPRO IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·November 2, 2020

    LIPISCAN CORONARY IMAGING CATHETER

    FDA Adverse Event
    Injury ·INFRAREDX INC.·Product code DQO·March 17, 2011

    TVC INSIGHT CATHETER

    FDA Adverse Event
    Injury ·INFRAREDX INC.·Product code OGZ·July 18, 2014

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·July 21, 2025

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·July 31, 2025

    DUALPRO IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OGZ·May 5, 2020

    MAKOTO INTRAVASCULAR IMAGING SYSTEM¿

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code IYO·November 17, 2021

    DUALPRO¿ IVUS+NIRS IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·INFRAREDX, INC.·Product code OBJ·June 20, 2019