Data / Medical devices / Continuous, Minimal Ventilatory Support, Facility Use Ventilator / United States
FDA-registered makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT). 4 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
- Continuous, Minimal Ventilatory Support, Facility Use Ventilator
- Product code
- MNT
- Country
- United States
Makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 4 | December 14, 2012 | 0 | 19 | 9 | api.fda.gov |
| Resmed Corp | San Diego, CA, United States | Complaint file establishment, Manufacturer | 3 | June 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Orangemed, LLC | Santa Ana, CA, United States | Manufacturer, Specification developer | 1 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 1 | December 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, 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.