Sibel, 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
ANNE Pediatric510(k)Nov 22, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2022
ANNE Sleep510(k)Jul 11, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 11, 2022
ANNE One510(k)Sep 14, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 14, 2021