Brainlab , Ltd. - FDA 510(k) Cleared Devices
2
Total
2
Cleared
0
Denied
Brainlab, Ltd. is a medical device company specializing in digital medical technologies for improved patient outcomes. The company operates with a manufacturing facility in Petach-Tikva, IL.
Brainlab has received 2 FDA 510(k) clearances from 2 total submissions. The company's regulatory focus is entirely on Radiology devices. First clearance was achieved in 2023, with the most recent clearance in 2025, demonstrating continued active development and FDA engagement.
The company's cleared portfolio includes advanced imaging and surgical planning solutions within the Radiology category. Explore the specific device names, product codes, and clearance dates in the database for complete regulatory details.
2 devices