Data / Medical devices / Catheter, Oximeter, Fiber-Optic / United States
FDA-registered makers of Catheter, Oximeter, Fiber-Optic in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Catheter, Oximeter, Fiber-Optic (product code DQE). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Oximeter, Fiber-Optic
- Product code
- DQE
- Country
- United States
Makers of Catheter, Oximeter, Fiber-Optic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 8 | February 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 8 | February 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Manufacturer, Specification developer | 5 | July 2, 2014 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Specification developer | 2 | July 2, 2014 | 0 | 1 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | December 29, 1992 | 0 | 0 | 0 | api.fda.gov |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.