Medical Device Manufacturer · US , Mchenry , IL

Haemonetics Corp. - FDA 510(k) Cleared Devices

28 submissions · 28 cleared · Since 1980

Total

Cleared

Denied

Haemonetics Corp., is a global provider of blood and plasma supplies and services. Founded in the 1970s, the company expanded to offices in 16 countries and serves markets across Asia, Europe, and the Americas.

The company has received 28 FDA 510(k) clearances from 28 total submissions between 1980 and 2012. Anesthesiology devices represent the dominant category, including autotransfusion systems and blood recovery technologies. This regulatory record reflects the company's historical focus on perioperative blood management solutions.

Notable cleared devices include the ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM, CELL SAVER ELITE, and SMARTSUCTION product line. These technologies address surgical blood conservation and recovery across anesthesiology and general surgery specialties.

This company profile represents a historical regulatory record. No FDA 510(k) clearances have been submitted since 2012. Explore the complete device list, product codes, and clearance dates in the database.

FDA 510(k) Regulatory Record - Haemonetics Corp.

28 devices

1-12 of 28