Fresenius Medical Care Renal Therapies Group, LLC - FDA 510(k) Cleare...

Fresenius Medical Care Renal Therapies Group, LLC is a medical device manufacturer based in Waltham, US. The company specializes in renal therapy and dialysis technologies.

The company has received 50 FDA 510(k) clearances from 50 total submissions since 2013. 96% of submissions focus on Gastroenterology & Urology devices, reflecting the company's core expertise in dialysis and renal replacement therapies. The latest clearance was in 2026, confirming active regulatory engagement.

Recent cleared devices include hemodialysis systems, dialyzers, body composition monitors, and dialysate concentrates. The company's product portfolio addresses in-center dialysis, home therapies, and advanced fluid management solutions for kidney disease patients.

Explore the complete list of device names, product codes, and clearance dates in the database above.