Medtronic, Inc. - FDA 510(k) Cleared Devices

Medtronic, Inc. is a global medical device manufacturer headquartered in Mounds View, United States. The company develops and markets a broad range of medical devices across multiple therapeutic areas.

Medtronic maintains a strong FDA 510(k) regulatory track record with 208 FDA 510(k) cleared devices from 209 total submissions since 1981. The company specializes primarily in Cardiovascular devices, which represent 82% of its submission portfolio. Recent clearances include coronary perfusion cannulae, intracoronary shunts, venous cannulae, guidewires, deflectable catheter systems, and temporary pacing leads. Latest clearance in 2026 confirms active ongoing development and regulatory engagement.

Explore the complete database of device names, product codes, and individual clearance dates to review Medtronic's full regulatory history and recent submissions.

510(k) submissions have been managed by Medtronic Sofamor Danek as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.