Aevice Health Pte. , Ltd. 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
Aevice Wheeze Detection Module510(k)Sep 25, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
AeviceMD510(k)May 5, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 5, 2025
AeviceMD510(k)Jul 7, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 7, 2023