Data / Medical devices / Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs / United States
FDA-registered makers of Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs (product code PHO). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
- Product code
- PHO
- Country
- United States
Makers of Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs in the United States
| 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 | |
| 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 | |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Contract manufacturer | 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 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.