Medical Device Manufacturer · US , Lafayette , CO

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

35 submissions · 35 cleared · Since 2005

Total

Cleared

Denied

Medtronic Navigation, Inc. is based in Lafayette, US. The company specializes in surgical navigation and imaging systems for minimally invasive procedures.

The company has received 35 FDA 510(k) clearances from 35 total submissions since 2005. Neurology devices represent a dominant category, including cranial and laser ablation systems. The latest clearance in 2026 reflects continued regulatory activity and product innovation.

Recent cleared devices span multiple surgical specialties. StealthStation and Stealth AXiS™ platforms serve neurology, orthopedic, and ear, nose, and throat applications. The Visualase laser ablation system and O-arm O2 imaging system demonstrate the company's focus on advanced surgical guidance technologies.

Explore the full list of device names, product codes, and clearance dates to review the company's complete regulatory record.

FDA 510(k) Regulatory Record - Medtronic Navigation, Inc.

35 devices

1-12 of 35