Kerecis Limited FDA Approvals

0 new drug approvals and 6 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
Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus510(k)Jul 16, 2025	—	510(k)Substantially Equivalent (Special)	Jul 16, 2025
Kerecis SurgiBind (50241)510(k)Jul 15, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jul 15, 2025
Tendon Protect (50242)510(k)Jun 4, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 4, 2025
Kerecis Parvus (50207)510(k)Aug 21, 2024	—	510(k)Substantially Equivalent (Traditional)	Aug 21, 2024
Kerecis Silicone510(k)Jun 29, 2022	—	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022
Kerecis Reconstruct510(k)May 2, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 2, 2021