Data / Medical devices / Integrated Continuous Glucose Monitoring System, Factory Calibrated / United States
FDA-registered makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ). 3 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
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Product code
- QBJ
- Country
- United States
Makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | April 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dexcom, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 3 | June 8, 2026 | 0 | 9 | 3 | api.fda.gov |
| Dexcom, Inc. | Mesa, AZ, United States | Manufacturer, Manufacturer for export | 3 | June 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Flextronics America, LLC | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics International USA | Buffalo Grove, IL, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc | El Paso, TX, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract 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.