Boehringer Laboratories, LLC - FDA 510(k) Cleared Devices

Boehringer Laboratories, LLC is a leader in high-quality, precision medical devices with a manufacturing facility in Phoenixville, US. Founded in 1972, the company develops and manufactures innovative surgical and clinical care products serving hospitals and healthcare systems globally across 38 countries.

The company has received 5 FDA 510(k) clearances from 5 total submissions since its first clearance in 2013. Boehringer's devices span General & Plastic Surgery and Gastroenterology & Urology specialties, with recent cleared products including surgical retractors, tissue removal systems, gastric sizing tubes, and specialized drainage controllers. The company remains actively engaged in regulatory submissions, with its latest clearance in 2025.

Core product lines include suction regulators-trusted by hospitals for over 40 years-vacuum-assisted venous drainage (VAVD) controllers, gastric calibration systems, and external urinary management devices. The company holds 85 U.S. patents and applications across its product portfolio and serves 256 open heart programs and 372 bariatric programs with its specialized surgical technologies.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates to learn more about Boehringer Laboratories' regulatory history and device portfolio.