Haemonetics Corporation - FDA 510(k) Cleared Devices

Haemonetics Corporation, provides innovative medical technology solutions that improve the quality, effectiveness and efficiency of care. The company serves hospitals, plasma centers, and blood centers with a comprehensive suite of products. Haemonetics operates with a manufacturing facility in Braintree, US.

The company has received 7 FDA 510(k) clearances from 7 total submissions since its first clearance in 2016. Haemonetics specializes in hematology devices and blood management technologies, with recent cleared devices spanning hemostasis testing systems and autotransfusion platforms. The company remains active, with its latest FDA 510(k) clearance in 2025, demonstrating ongoing innovation and regulatory engagement.

Haemonetics' cleared device portfolio includes hemostasis analysis systems for coagulation testing and cell salvage autotransfusion systems for surgical and cardiovascular applications. These products support critical clinical workflows in hospital operating rooms, blood centers, and plasma collection facilities.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database to review Haemonetics' full regulatory record.