Data / Medical devices / Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs (PHO): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs (product code PHO, Class 3). 5 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 3, 2026.
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- Product code
- PHO
- Device class
- 3
- Medical specialty
- Unknown
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Sweden | 2 |
| Canada | 1 |
| Austria | 1 |
Makers of Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
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 |
|---|---|---|---|---|---|---|---|---|
| Lung Bioengineering Inc | Silver Spring, MD, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Traferox Technologies Inc. | Mississauga Ontario, Canada | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Xvivo Perfusion AB | Molndal Vastra Gotaland, Sweden | Complaint file establishment, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Xvivo Perfusion, Inc. | Golden, CO, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Xvivo Perfusion, Inc. | Aurora, CO, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Apotek Produktion & Laboratorier AB | Umea Vasterbotten, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresenius Kabi Austria GMBH | GRAZ Steiermark, Austria | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Transmedics, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.