The products listed in this section include some of the newest medical technology available. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.
Please note: The lists in this section do not include every approval. Complete lists of different approval activities can be found in the following sections:
- PMA Approvals: New or high-risk medical devices that require a more rigorous premarket review than the 510(k) pathway.
- 510(k) Clearances: New devices that are "substantially equivalent" to a device that is already legally marketed for the same use.
- Humanitarian Device Exemptions (HDE): Devices that treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per year.