How to tell if a medical device is FDA approved or not

How Do You Know if the FDA Approved, Cleared, or Authorized a Medical Device?

The FDA provides several ways for you to check if the FDA approved or cleared a medical device or, as described below, if the FDA authorized the device to be used during a public health emergency.

Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA.

To search for FDA-approved or FDA-cleared products by device name or company name:

1. Go to the Devices@FDA Database.
2. In the Enter a search term in the space below field, type the name of the device or the company name. You can type the exact name of a specific device or a generic name for a category of devices (such as pacemaker).
3. Click Search.

Example: Search for Pacemaker

Check for Products in the De Novo Database: The FDA may review medical devices through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. A device reviewed through this pathway may be authorized for marketing in the United States. The term "De Novo" is Latin for "new."

To search for products by device name or company name:

• Go to the Device Classification Under Section 513(f)(2)(De Novo) database.
• Do one of the following:
  • In the Device Name field, type the device name and click Search.
  • In the Requester Name field, type the company name and click Search.