Data / Medical devices / Oximeter To Measure Hemoglobin / United States
FDA-registered makers of Oximeter To Measure Hemoglobin in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Oximeter To Measure Hemoglobin (product code GLY). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Oximeter To Measure Hemoglobin
- Product code
- GLY
- Country
- United States
Makers of Oximeter To Measure Hemoglobin 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 | Manufacturer, Manufacturer for export, Remanufacturer | 2 | December 2, 1999 | 0 | 0 | 0 | api.fda.gov |
| Instrumentation Laboratory Co. | Bedford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumentation Laboratory Co. | Orangeburg, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation Diabetes Products | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Biomedical Corporation | Billerica, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Opti Medical Systems Inc. | Roswell, GA, United States | 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.