Data / Medical devices / Gas-Machine, Anesthesia / United States
FDA-registered makers of Gas-Machine, Anesthesia in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Gas-Machine, Anesthesia (product code BSZ). 9 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Gas-Machine, Anesthesia
- Product code
- BSZ
- Country
- United States
Makers of Gas-Machine, Anesthesia in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Madison, WI, United States | Manufacturer, Manufacturer for export | 23 | March 28, 2023 | 0 | 2 | 1 | api.fda.gov |
| Infinium Medical, Inc. | Largo, FL, United States | Manufacturer, Repackager or relabeler | 3 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 3 | January 12, 2018 | 0 | 9 | 1 | api.fda.gov |
| Precision Fluidics Division Parker Hannifin Corp. | Hatfield, PA, United States | Manufacturer | 3 | November 9, 2006 | 0 | 0 | 0 | api.fda.gov |
| Accutron, Inc. | Phoenix, AZ, United States | Manufacturer | 2 | November 23, 2005 | 0 | 1 | 1 | api.fda.gov |
| Codonics, Inc. | Middleburg Heights, OH, United States | Complaint file establishment, Manufacturer, Remanufacturer | 2 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer, Manufacturer for export | 1 | January 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 1 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Oricare Inc. | Quakertown, PA, United States | Specification developer | 1 | May 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer | 0 | 0 | 3 | 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.