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Continuous Glucose Monitor Retrospective Data Analysis Software
FDA product code PHV · Class 1 · Clinical Chemistry
42
Registered devices
2,102
Adverse events
3
Recalls
1
510(k) clearances
Devices with this code
Tandem Source — Tandem Diabetes Care, Inc.Eversense® DMS — SENSEONICS, INCORPORATEDCenter Health PHV — CENTER HEALTH INCORPORATEDLibreView — ABBOTT DIABETES CARE INCCornerstones4Care® Powered by Glooko Mobile Application — GLOOKO, INC.CareLink™ Personal — MEDTRONIC MINIMED, INC.Welldoc — WELLDOC, INC.FreeStyle Libre Pro — ABBOTT DIABETES CARE INCEversense® DMS Pro — SENSEONICS, INCORPORATEDOmnipod Discover — Insulet CorporationWelldoc — WELLDOC, INC.Sugarmate, Alexa Skill Application — Sugarmate, LLCCareLink™ Software — MEDTRONIC MINIMED, INC.Dexcom Clarity — Dexcom, Inc.Onduo — VERILY LIFE SCIENCES LLCSugarmate, iOS Mobile Application — Sugarmate, LLCGlooko Mobile Application — GLOOKO, INC.Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users — WELLDOC, INC.Eversense DMS — SENSEONICS, INCORPORATEDSugar.IQ™ — MEDTRONIC MINIMED, INC.Bigfoot Unity Report — Bigfoot Biomedical, Inc.Onduo — VERILY LIFE SCIENCES LLCWelldoc — WELLDOC, INC.LibreView Government — ABBOTT DIABETES CARE INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-11 | Medtronic MiniMed, Inc. | CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values en |
| 2025-10-21 | Medtronic MiniMed, Inc. | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incor |
| 2016-08-05 | Medtronic Inc. | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error. |
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