Data / Medical devices / Continuous, Ventilator, Home Use / United States
FDA-registered makers of Continuous, Ventilator, Home Use in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Continuous, Ventilator, Home Use (product code NOU). 1 has a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Continuous, Ventilator, Home Use
- Product code
- NOU
- Country
- United States
Makers of Continuous, Ventilator, Home Use in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Breas Medical, Inc. | N Billerica, MA, United States | Complaint file establishment, Specification developer | 4 | January 13, 2025 | 0 | 5 | 1 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 0 | 2 | 1 | api.fda.gov | |
| Respironics, Inc. | Mount Pleasant, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Corp | Lithia Spgs, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 1 | 1 | api.fda.gov | |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Specification developer | 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.