Data / Medical devices / Oximeter To Measure Hemoglobin
Oximeter To Measure Hemoglobin (GLY): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Oximeter To Measure Hemoglobin (product code GLY, Class 2, 21 CFR 864.7500). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on May 5, 2005, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- GLY
- Device class
- 2
- Regulation
- 864.7500
- Medical specialty
- Hematology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Israel | 1 |
| Switzerland | 1 |
Makers of Oximeter To Measure Hemoglobin
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 | |
| Orsense Ltd | Tel Aviv Yafo Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 5, 2005. 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.