Data / Medical devices / Mixer, Breathing Gases, Anesthesia Inhalation / United States
FDA-registered makers of Mixer, Breathing Gases, Anesthesia Inhalation in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR). 8 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
- Mixer, Breathing Gases, Anesthesia Inhalation
- Product code
- BZR
- Country
- United States
Makers of Mixer, Breathing Gases, Anesthesia Inhalation in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 7 | December 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Precision Fluidics Division Parker Hannifin Corp. | Hatfield, PA, United States | Manufacturer | 4 | September 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Precision Medical, Inc. | Northampton, PA, United States | Manufacturer | 2 | August 13, 2009 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 2 | July 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Bio-Med Devices, Inc. | Guilford, CT, United States | Manufacturer | 1 | October 7, 1993 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 1 | May 21, 1986 | 0 | 0 | 0 | api.fda.gov |
| Sechrist Industries, Inc. | Anaheim, CA, United States | Manufacturer | 1 | August 10, 1999 | 0 | 0 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 1 | July 23, 1993 | 0 | 0 | 0 | api.fda.gov |
| Contech Holdings LLC | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, 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.