Data / Medical devices / Apparatus, Nitric Oxide Delivery / United States
FDA-registered makers of Apparatus, Nitric Oxide Delivery in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Apparatus, Nitric Oxide Delivery (product code MRN). 3 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Apparatus, Nitric Oxide Delivery
- Product code
- MRN
- Country
- United States
Makers of Apparatus, Nitric Oxide Delivery in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Manufacturer, Remanufacturer | 17 | December 6, 2023 | 0 | 5 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 3 | March 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Manufacturer | 2 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| C2C Development, LLC | Melbourne, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vero Biotech Inc. | Livingston, TN, 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.