Organogenesis, Inc. FDA Approvals

0 new drug approvals and 2 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
FortiShield (Biosynthetic Wound Matrix)510(k)May 2, 2023	—	510(k)Substantially Equivalent (Traditional)	May 2, 2023
PuraPly Micronized Wound Matrix (PuraPly MZ)510(k)Jul 1, 2022	—	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022