Data / Medical devices / Continuous Glucose Monitor Retrospective Data Analysis Software / United States
FDA-registered makers of Continuous Glucose Monitor Retrospective Data Analysis Software in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Continuous Glucose Monitor Retrospective Data Analysis Software (product code PHV). 1 has a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Continuous Glucose Monitor Retrospective Data Analysis Software
- Product code
- PHV
- Country
- United States
Makers of Continuous Glucose Monitor Retrospective Data Analysis Software in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dexcom, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | August 19, 2014 | 0 | 0 | 0 | api.fda.gov |
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beta Bionics, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Center Health Inc. | Hillsborough, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glooko Inc | Palo Alto, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insulet Corporation | Acton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Senseonics, Inc. | Germantown, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidepool Project | Palo Alto, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teladoc Health, Inc. - Lewisville | Lewisville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welldoc | Columbia, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.