Sibel Health, Inc. FDA Approvals

0 new drug approvals and 5 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 Maternal510(k)Feb 26, 2026Obstetrics/Gynecology	Obstetrics/Gynecology	510(k)Substantially Equivalent (Traditional)	Feb 26, 2026
ANNE View, Central Hub510(k)Jan 8, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 8, 2025
ANNE Chest510(k)Jun 3, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 3, 2024
ANNE Limb510(k)May 28, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 28, 2024
ANNE One510(k)Aug 10, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023