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Continuous Glucose Monitor Retrospective Data Analysis Software
FDA product code PHV · Class 1 · Clinical Chemistry
42
Registered devices
2,060
Adverse events
2
Recalls
1
510(k) clearances
Devices with this code
Dexcom Clarity — Dexcom, Inc.Welldoc — WELLDOC, INC.Cornerstones4Care® Powered by Glooko Mobile Application — GLOOKO, INC.Welldoc — WELLDOC, INC.Sugar.IQ™ — MEDTRONIC MINIMED, INC.Eversense DMS Pro — SENSEONICS, INCORPORATEDSugarmate, iOS Mobile Application — Sugarmate, LLCBigfoot Unity Report — Bigfoot Biomedical, Inc.Dexcom Portrait on the Web — SWEETSPOT DIABETES CARE, INC.Welldoc — WELLDOC, INC.Dexcom CLARITY — SWEETSPOT DIABETES CARE, INC.Omnipod Discover — Insulet CorporationSugar.IQ™ — MEDTRONIC MINIMED, INC.Onduo — VERILY LIFE SCIENCES LLCCareLink™ Personal — MEDTRONIC MINIMED, INC.Eversense DMS — SENSEONICS, INCORPORATEDCareLink™ — MEDTRONIC MINIMED, INC.Tandem Source — Tandem Diabetes Care, Inc.Welldoc App for Diabetes in Pregnancy and Insulin Pump Users — WELLDOC, INC.Eversense® DMS Pro — SENSEONICS, INCORPORATEDCareLink™ Personal — MEDTRONIC MINIMED, INC.Sugarmate, Alexa Skill Application — Sugarmate, LLCFreeStyle Libre — ABBOTT DIABETES CARE INCEversense® DMS — SENSEONICS, INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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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