Barco N.V. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
LCD Monitor (MDEC-2523)510(k)Dec 13, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 13, 2024
Coronis OneLook510(k)Aug 2, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 2, 2024
Nio Color 8MP (MDNC-8132)510(k)Dec 11, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 11, 2023
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)510(k)Mar 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Mar 21, 2023
Demetra Dermatoscope BDEM-01510(k)Mar 11, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Mar 11, 2022
MDPC-8127510(k)Apr 15, 2021Pathology	Pathology	510(k)Substantially Equivalent (Traditional)	Apr 15, 2021
Demetra Analytics Toolkit510(k)Feb 18, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 18, 2021