Bluewind Medical , Ltd. FDA Approvals

0 new drug approvals and 4 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
Revi System510(k)Jul 28, 2026Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 28, 2026
Revi System510(k)Dec 12, 2025Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Dec 12, 2025
Revi System510(k)May 2, 2024Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	May 2, 2024
Revi System510(k)Aug 16, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Unknown (Direct)	Aug 16, 2023