57% of FDA-Registered Medical-Device Manufacturers Are in Just Two Countries

Yes — both 'Manufacture Medical Device' and 'Manufacture Medical Device for Another Party (Contract Manufacturer)' are establishment types in the FDA registry. CMOs file under the contract-manufacturer type; OEMs file under the standard type. Our table above uses 'Manufacture Medical Device' as the broadest manufacturer type.

China is the second-largest source of medical devices exported to the U.S. market by establishment count. Any facility outside the U.S. that wants to export to the U.S. must register with the FDA — the registry captures global supply-chain breadth, not just U.S.-domestic production.