Ovigenex, LLC 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
CollOvine Wound Powder510(k)Feb 10, 2026	—	510(k)Substantially Equivalent (Traditional)	Feb 10, 2026
CollOvine Wound Dressing510(k)Jun 20, 2025	—	510(k)Substantially Equivalent (Traditional)	Jun 20, 2025