Medtronic, Inc.

7 AI-enabled medical devices from Medtronic, Inc. on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2025-10-28P220012/S059Aurora EV ICD (DVEA3E4)Medtronic, Inc.Cardiovascular
2023-12-06K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.Cardiovascular
2023-04-26K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM ApplicationMedtronic, Inc.Cardiovascular
2023-04-05K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification SystemMedtronic, Inc.Cardiovascular
2022-08-25K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.Cardiovascular
2021-06-11K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.Cardiovascular
2017-02-23K162855Reveal LINQMedtronic, Inc.Cardiovascular

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