Data / Medical devices / Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph / United States
FDA-registered makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph (product code CHL). 13 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 3, 2026.
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- Device
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Product code
- CHL
- Country
- United States
Makers of Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Nova Biomedical Corporation | Waltham, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Remanufacturer | 16 | July 17, 2018 | 0 | 4 | 0 | api.fda.gov |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Manufacturer for export, Remanufacturer | 9 | July 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 8 | March 27, 2020 | 0 | 2 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc | East Walpole, MA, United States | Complaint file establishment, Specification developer | 7 | March 27, 2020 | 0 | 15 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 5 | August 10, 2023 | 0 | 7 | 0 | api.fda.gov |
| Abbott Point Of Care Inc. | Princeton, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | May 2, 2025 | 0 | 14 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 4 | August 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medica Corp. | Bedford, MA, United States | Manufacturer | 3 | June 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| Opti Medical Systems Inc. | Roswell, GA, United States | Manufacturer | 2 | August 22, 2013 | 0 | 1 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 2 | December 17, 2003 | 0 | 1 | 0 | api.fda.gov |
| Bionostics, Inc. | Devens, MA, United States | Contract manufacturer, Manufacturer | 1 | January 3, 1994 | 0 | 0 | 0 | api.fda.gov |
| Phoenix Diagnostics, Inc. | Natick, MA, United States | Manufacturer | 1 | June 12, 1990 | 0 | 0 | 0 | api.fda.gov |
| Radiometer Minneapolis | New Brighton, MN, United States | Manufacturer, Manufacturer for export | 1 | August 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter, Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ELITechGroup Inc | Logan, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Supplies & Technology, Inc. | Doral, FL, United States | Remanufacturer, Repackager or relabeler | 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.