FDA Device Intelligence
Home › SENSEONICS, INCORPORATED › Eversense® DMS

Eversense® DMS

SENSEONICS, INCORPORATED · Model FG-5700-01-300 · UDI-DI 00817491021878

PHV Prescription
1
510(k) clearances
2,081
Adverse events
2
Recalls
15
Facilities

Description

Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.

Recalls

DateFirmReason
2025-10-21Medtronic 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 incorrect data displayed
2016-08-05Medtronic Inc.Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.