Medtronic - FDA 510(k) Cleared Devices

Medtronic is an American-Irish medical device company with operational headquarters in Minneapolis, Minnesota. The company operates globally across more than 150 countries and is the largest medical device company in the world by revenue.

Medtronic has received 32 FDA 510(k) clearances from 32 total submissions since 2007. The company's regulatory portfolio is dominated by cardiovascular devices, including oxygenation systems, arterial filters, cardioplegia delivery systems, and catheter-based interventions. Medtronic also maintains a significant presence in orthopedic spinal systems. The latest FDA 510(k) clearance was received in 2026, confirming active regulatory engagement.

Medtronic is recognized for developing world-first technologies including implantable pacemakers, implantable cardioverter-defibrillators (ICDs), remote monitoring systems, and miniaturized devices such as the world's smallest pacemaker and spinal cord stimulator. These innovations reflect the company's long-standing focus on cardiac and neurological therapies.

Explore the complete regulatory record by reviewing individual device names, product codes, and FDA 510(k) clearance dates in the database.