Bauerfeind AG - FDA 510(k) Cleared Devices

Bauerfeind AG, is a medical device manufacturer specializing in orthopedic braces, compression therapy systems, and orthopedic insoles. The company operates with a manufacturing facility in Zeulenroda-Triebes, Germany, and serves patients across multiple therapeutic areas including musculoskeletal support and venous care.

The company has received 2 FDA 510(k) clearances from 2 total submissions. Bauerfeind's FDA 510(k) cleared devices span cardiovascular and general hospital categories, with clearances granted between 2011 and 2013. This represents a historical regulatory record; the company has not received FDA 510(k) clearances in more than a decade.

Bauerfeind's product portfolio includes active orthoses and stabilization braces for the foot, ankle, knee, hip, back, shoulder, elbow, wrist, and hand. The company also manufactures medical compression systems for venous conditions and custom orthopedic insoles designed to provide biomechanical support and natural foot function. All products are manufactured to "Made in Germany" quality standards.

Explore the complete list of device names, product codes, and clearance dates in the FDA 510(k) database to review Bauerfeind's regulatory history and cleared device specifications.