862 results
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28ms
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Sources: EU EUDAMED, US FDA
BARCO N.V.
FDA registration
BARCO N.V.·9 products·🇧🇪 Belgium
NEXXIS
FDA Adverse Event
Malfunction
·BARCO N.V.·Product code DXJ·March 26, 2026
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Enforcement
Class II
·Completed·Barco N.V.·July 17, 2024
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
FDA Enforcement
Class II
·Terminated·Barco N.V.·December 12, 2018
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
FDA Enforcement
Class II
·Terminated·Barco N.V.·March 10, 2021
Barco MDSC-8527 NXF, Part Number K9352421
FDA Enforcement
Class II
·Ongoing·Barco N.V.·February 14, 2024
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
FDA Recall
Terminated
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code OWB·March 30, 2017
Barco MDSC-8527 NXF, Part Number K9352421
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code KQM·December 20, 2023
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 2025
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display
FDA Recall
Completed
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·April 24, 2024
Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY
FDA Recall
Terminated
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code PGY·January 22, 2021
Barco, Inc.
Manufacturer
🇺🇸 United States·1 Basic UDI-DI·3 Devices·1 Importer
Barco (Suzhou) Healthcare Technology Co., Ltd.
Manufacturer
🇨🇳 China·1 Basic UDI-DI·5 Devices
Barco NV
Manufacturer
🇧🇪 Belgium·12 Basic UDI-DIs·323 Devices
Barco
Device
EU MDR
·
Eu Md Class 1
·Barco, Inc.·On the market
Barco
Device
EU MDR
·
Eu Md Class 1
·Barco (Suzhou) Healthcare Technology Co., Ltd.·On the market
Barco
Device
EU MDR
·
Eu Md Class 1
·Barco (Suzhou) Healthcare Technology Co., Ltd.·On the market
Barco
Device
EU MDR
·
Eu Md Class 1
·Barco (Suzhou) Healthcare Technology Co., Ltd.·On the market
Barco
Device
EU MDR
·
Eu Md Class 1
·Barco (Suzhou) Healthcare Technology Co., Ltd.·On the market