Fresenius Medical Care - FDA 510(k) Cleared Devices

Fresenius Medical Care, is a global provider of dialysis products and services. The company operates with a manufacturing facility in Lexington, US. It specializes in Gastroenterology & Urology devices for kidney replacement therapy and renal care.

The company has received 7 FDA 510(k) clearances from 7 total submissions. All submissions focus on Gastroenterology & Urology devices. Fresenius Medical Care's regulatory activity spans from 2000 to 2024, with its most recent clearance in 2024, demonstrating continued innovation in renal care technologies.

The company's cleared devices include hemodialysis systems, dialysis machines, concentrate formulations, and vascular access products. These products support both in-center and home-based dialysis therapies. Fresenius Medical Care maintains an active presence in the FDA 510(k) clearance database with recent submissions demonstrating ongoing product development.

Explore the complete list of device names, product codes, and clearance dates in the database to review Fresenius Medical Care's full regulatory history.