Brainlab AG - FDA 510(k) Cleared Devices

Brainlab AG, is a digital medical technology company specializing in image-guided surgery and neurology devices. The company operates with a manufacturing facility in Heimstetten, Germany, and develops innovative surgical navigation and alignment systems for cranial, spine, and neurosurgical procedures.

Brainlab has received 135 FDA 510(k) clearances from 135 total submissions since its first clearance in 1996. The company maintains a strong regulatory presence in neurology devices, with recent clearances spanning surgical navigation systems, robotic alignment platforms, trajectory planning software, and intraoperative imaging technologies. The latest FDA 510(k) clearance was granted in 2025, demonstrating continued active development and market engagement.

The company's cleared device portfolio includes advanced surgical navigation systems, robotic-assisted alignment modules for cranial and spine surgery, image-guided surgery platforms, and specialized software for trajectory planning and lead localization. These technologies support neurosurgeons in precision-guided procedures and intraoperative decision-making.

Explore the complete list of Brainlab device names, product codes, and FDA 510(k) clearance dates in the database.

510(k) submissions have been managed by Msquared Associates, Inc. as regulatory consultant.