The U.S. Food and Drug Administration (FDA) regulates medical devices in the U.S. The FDA keeps extensive databases on these devices containing lists of the devices, their safety records, pre-market notifications, and pre-market approval notices, to name a few.
Section 510(k) of the Food, Drug and Cosmetic Act requires regulated medical device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket …