Data / Medical devices / Continuous Glucose Monitor Retrospective Data Analysis Software
Continuous Glucose Monitor Retrospective Data Analysis Software (PHV): 14 FDA-registered makers in 3 countries
14 establishments in 3 countries are registered with the FDA to make Continuous Glucose Monitor Retrospective Data Analysis Software (product code PHV, Class 1, 21 CFR 862.2120). 1 of them has a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on August 19, 2014, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHV
- Device class
- 1
- Regulation
- 862.2120
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Israel | 1 |
| Sweden | 1 |
Makers of Continuous Glucose Monitor Retrospective Data Analysis Software
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 |
|---|---|---|---|---|---|---|---|---|
| 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 | |
| Dreamed Diabetes Ltd | Petah Tikva Tel Aviv, Israel | 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 | |
| Onetwo Analytics AB | Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 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 August 19, 2014. 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.