Ortho8, Inc. FDA Approvals

0 new drug approvals and 3 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
CIRCUL8 Connect DVT Prevention Device510(k)Jun 3, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jun 3, 2022
Circul8 Pro510(k)Nov 15, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Nov 15, 2021
CIRCUL8 Luxe DVT Prevention Device510(k)Sep 8, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 8, 2021