TransMedics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
TransMedics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: OCS Heart Leukocyte Depleting Filter, OCS Lung Donor Flush Set, OCS Lung Solution
3
Total
3
Cleared
0
Denied
TransMedics, Inc. has 3 FDA 510(k) cleared medical devices. Based in Andover, US.
Last cleared in 2023. Active since 2021. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by TransMedics, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Biologics Consulting Group, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - TransMedics, Inc.
3 devices