Brainlab is one of 387 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
3
Total
3
Cleared
0
Denied
Brainlab, is a medical device company specializing in digital medical technologies for surgery and radiation therapy. The company has innovated for over 25 years in treating brain and body conditions, including cancer. Brainlab operates with a manufacturing facility in West Germany.
The company holds 3 FDA 510(k) clearances from 3 total submissions, spanning radiology and neurology device categories. Clearances were granted between 1992 and 2000. Brainlab is a historical record in the FDA 510(k) database, with no recent submissions.
Historical cleared devices include stereotactic arc systems, brachytherapy modules, and radiosurgery modules. These technologies represent the company's core focus on image-guided surgical and radiotherapeutic solutions.
Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.
FDA 510(k) Regulatory Record - Brainlab
3 devices