Medical Device Manufacturer · US , Andover , MA

TransMedics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2021

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - TransMedics, Inc. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Oct 31, 2023

OCS Heart Leukocyte Depleting Filter

Cardiovascular · 173d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 15, 2026