Given Imaging Ltd. (Medtronic) FDA Approvals

0 new drug approvals and 2 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
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E510(k)Jun 30, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Special)	Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E510(k)Aug 27, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Aug 27, 2021