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. Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared Nov 18, 2022

OCS Lung Donor Flush Set

Gastroenterology & Urology · 88d

Cleared Jul 29, 2021

OCS Lung Solution

Gastroenterology & Urology · 90d

Data Source

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

Last updated: May 15, 2026