TransMedics, 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
OCS Heart Leukocyte Depleting Filter510(k)Oct 31, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 31, 2023
OCS Lung Donor Flush Set510(k)Nov 18, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
OCS Lung Solution510(k)Jul 29, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 29, 2021