TRANSMEDICS, INC.

FDA Device Registration & Listing · Andover, MA, US · Registration 3003152463

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003152463
FEI Number
3003152463
Entity Name
TRANSMEDICS, INC.
City/State/Country
Andover, MA, US
Establishment Address
200 MINUTEMAN RD STE 302, Andover, MA 01810, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
TransMedics (Owner Number: 10045349)
Owner / Operator Contact Address
200 Minuteman Road, Suite 302, Andover, MA 01810, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K211314
PMA Number
N/A

All Registered Proprietary Names

OCS Lung System OCS Lung Solution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PHO Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs Unknown Class 3 N/A 2018-06-05
QBA Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation Unknown Class 3 N/A 2018-06-05
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2021-08-11

Official Correspondent

Christy Foreman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TransMedics
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3028907862 XVIVO PERFUSION, INC. Aurora, CO, US
3003708554 FRESENIUS KABI AUSTRIA GMBH GRAZ Steiermark, AT
1220477 ISOMEDIX OPERATIONS INC. Northborough, MA, US
3012102437 Synergy Health AST, LLC Petaluma, CA, US
3009736925 XVIVO PERFUSION, INC. Golden, CO, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003152463. Last updated year: 2026. Please use registration number 3003152463 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.