Steris - FDA 510(k) Cleared Devices

Steris, is a leading global provider of products and services supporting patient care with emphasis on infection prevention. The company operates with a manufacturing facility in Mentor, Ohio, and serves hospitals, surgery centers, pharmaceutical manufacturers, and research laboratories worldwide.

Steris has received 19 FDA 510(k) clearances from 21 total submissions since 2021. The company specializes in General Hospital devices, which represent 81% of its regulatory submissions. Recent clearances include sterilization systems, chemical indicators, biological indicators, and washer disinfectors. The latest clearance in 2025 demonstrates continued active development and regulatory engagement.

The company's product portfolio spans sterilization solutions, sterile processing equipment, surgical instrument cleaning chemistries, endoscope reprocessing systems, and sterility assurance monitoring devices. Steris also provides contract sterilization services including gamma irradiation, ethylene oxide sterilization, and vaporized hydrogen peroxide processing.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.