Medical Device Manufacturer · US , Waukegan , IL

Cardinal Health, Inc. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 2006

Total

Cleared

Denied

Cardinal Health, Inc. is an American multinational health care services company headquartered in Dublin, Ohio. The company specializes in pharmaceutical distribution and medical product manufacturing, serving over 100,000 locations across the United States.

Cardinal Health has received 26 FDA 510(k) clearances from 26 total submissions between 2006 and 2017. The company's regulatory focus centers on surgical gloves and protective apparel, including sterile and powder-free formulations. This historical record reflects the company's established presence in General Hospital device categories.

The company manufactures a range of medical and surgical products, including gloves, surgical apparel, and fluid management solutions. Cardinal Health provides medical products to over 75 percent of hospitals in the United States and operates one of the largest radiopharmacy networks in the country.

This profile represents a historical regulatory record. For detailed information on specific device names, product codes, and clearance dates, explore the complete 510(k) submission history.

FDA 510(k) Regulatory Record - Cardinal Health, Inc.

26 devices

1-12 of 26