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Glooko Web Application

GLOOKO, INC. · Model xx.yy (xx is model year and yy is a serial number) · UDI-DI 00855093008026

PHV
1
510(k) clearances
2,102
Adverse events
3
Recalls
16
Facilities

Description

Glooko Web Application is a web based application that displays and analyzes retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)

Recalls

DateFirmReason
2026-09-11Medtronic 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 entered by healthcare
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.

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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.