What inspections does the Food and Drug Administration have to check the hospital consumables certificate?

The US Food and Drug Administration only inspects drugs and medical devices. To check medical instruments, including surgical instruments, the hospital only needs to provide a copy of the license of the instrument manufacturer or operating company (which must be stamped with a red seal), a copy of the product registration certificate of the instrument (which must be stamped with a red seal) and a copy of the business license (which must be stamped with a red seal), namely, two certificates of 1. Others don't need it, and neither do they.