Imds Operations B.V. FDA Approvals

0 new drug approvals and 5 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
FlowGuide (FG60F); GuidionShort (GS60F)510(k)Apr 17, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 17, 2025
ShapeIT (SI014135)510(k)Sep 3, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 3, 2024
Micro Rx510(k)Jul 13, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 13, 2023
ReCross510(k)Jul 15, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 15, 2021
Guidion510(k)Mar 31, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 31, 2021