Opsens, Inc. FDA Approvals

0 new drug approvals and 4 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
OptoMonitor 3510(k)Jan 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 16, 2026
OptoMonitor 3510(k)Feb 12, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 12, 2025
PacePro Wire510(k)May 24, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 24, 2024
SavvyWire510(k)Sep 14, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 14, 2022