Deroyal Industries is one of 19736 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Deroyal Industries - FDA 510(k) Cleared Devices
Recent clearances: PROTOCOL Incision Dressing
1
Total
1
Cleared
0
Denied
Deroyal Industries, is a global medical device manufacturer founded in 1973, with a manufacturing facility in Powell, US. The company offers over 25,000 healthcare products across patient care, orthopedic, surgical, and wound care categories. DeRoyal serves healthcare providers internationally, distributing to over 70 countries.
DeRoyal has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on General & Plastic Surgery devices. The cleared device, PROTOCOL Incision Dressing, was approved in 2015. The company is currently inactive, with no FDA 510(k) submissions in more than five years, and should be treated as a historical regulatory record.
Beyond its cleared surgical device, DeRoyal's product portfolio encompasses advanced wound care, temperature monitoring systems, orthopedic bracing, and the Continuum® inventory management platform using RFID technology. The company also provides OEM manufacturing, metals fabrication, and sterilization services to healthcare partners.
Explore the company's FDA 510(k) clearance history, device names, product codes, and approval dates in the database.
FDA 510(k) Regulatory Record - Deroyal Industries
1 devices