Data / Medical devices / Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation (QQK): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation (product code QQK, Class 3). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QQK
- Device class
- 3
- Medical specialty
- Unknown
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| United Kingdom | 2 |
| Germany | 1 |
Makers of Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Organox Limited | Oxford Oxfordshire, United Kingdom | Manufacturer, Repackager or relabeler | 0 | 1 | 1 | 0 | api.fda.gov | |
| Transmedics, Inc. | Andover, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Technologies Ltd. | ASHFORD Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC - Muenchberg | Helmbrechts Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RAUMEDIC, Incorporated. | Mills River, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.