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Eversense® Mobile App iOS

SENSEONICS, INCORPORATED · Model FG-5501-01-300 · UDI-DI 00817491022370

QHJ Prescription
0
510(k) clearances
2,444
Adverse events
1
Recalls
8
Facilities

Description

Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.

Recalls

DateFirmReason
2019-09-18Senseonics, Inc.Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

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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.