Data / Medical devices / United States / Transmedics, Inc.

Transmedics, Inc.: FDA-registered device maker in Andover, MA, United States, 3 510(k) clearances and 3 PMA approvals

Name: Transmedics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Transmedics, Inc. is registered with the FDA (registration 3003152463) in Andover, MA, United States. It lists 6 device types. The FDA files 3 510(k) clearances and 3 PMA approvals under its listings, the newest dated October 31, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003152463
Address: 200 Minuteman RD Ste 302, Andover, MA, United States, 01810
Owner or operator: TransMedics (10045349)
Roles: Manufacturer, Specification developer
First device listed: June 5, 2018
Registered through: 2026
Brand names listed: OCS Liver, OCS Lung Donor Flush Set, OCS Lung Solution, OCS Lung System, Organ Care System (OCS) Heart

Devices it lists

Device	Product code	Class	Role	Source
Filter, Blood, Cardiopulmonary Bypass, Arterial Line	DTM	2	Manufacturer	accessdata.fda.gov
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation	QQK	3	Manufacturer	accessdata.fda.gov
Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation	QBA	3	Manufacturer	accessdata.fda.gov
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs	PHO	3	Manufacturer	accessdata.fda.gov
Organ Care System (Ocs) Heart System	QIK	3	Manufacturer	accessdata.fda.gov
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 31, 2023	K231362	OCS Heart Leukocyte Depleting Filter	DTM	Substantially Equivalent	TransMedics, Inc.	accessdata.fda.gov
November 18, 2022	K222535	OCS Lung Donor Flush Set	MSB	Substantially Equivalent	TransMedics, Inc.	accessdata.fda.gov
July 29, 2021	K211314	OCS Lung Solution	MSB	Substantially Equivalent	TransMedics, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 28, 2021	P200031	Organ Care System (OCS) Liver	QQK	12	May 13, 2026	accessdata.fda.gov
September 3, 2021	P180051	Organ Care System (OCS) Heart System	QIK	8	December 16, 2025	accessdata.fda.gov
March 22, 2018	P160013	Organ Care System (OCS) Lung System	QBA	18	May 13, 2026	accessdata.fda.gov

Compare with other makers

Updated May 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.