Hoya Corporation is one of 19525 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hoya Corporation - FDA 510(k) Cleared Devices
Recent clearances: APACERAM BONE GRAFT SUBSTITUTE
1
Total
1
Cleared
0
Denied
Hoya Corporation, is a global optical and medical device manufacturer with a manufacturing facility in Chevy Chase, US. The company operates across life care and information technology sectors, producing eyeglasses, contact lenses, intraocular lenses, endoscopes, and semiconductor-related optical products.
Hoya has received 1 FDA 510(k) clearance from 1 total submission. The company's cleared device falls within the Orthopedic category. The clearance was granted in 2012. Hoya's FDA regulatory activity in this area is now historical, with no submissions in the past decade.
The cleared device was APACERAM BONE GRAFT SUBSTITUTE, an orthopedic implant material. This reflects Hoya's diversified portfolio in medical devices beyond its core optical and imaging businesses. The company acquired orthopedic capabilities through the 2012 purchase of Nippon Unitech, a Japanese metal orthopedic implant manufacturer.
Explore the device clearance details, product codes, and submission dates in the 510(k) database records below.
FDA 510(k) Regulatory Record - Hoya Corporation
1 devices