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 214 FDA 510(k) cleared devices from 215 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.

Regulatory submissions have been managed by Underwriters Laboratories, Inc., Regulatory Technology Services, LLC and Medtronic Sofamor Danek. 3 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.