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ClearPoint Neuro, Inc. FDA Approvals
0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| ClearPoint System (Software Version 3.0)510(k)Jan 24, 2025Neurology |
| SmartFlow Neuro Cannula510(k)Nov 13, 2024Neurology |
| Bone Anchor (NGS-BA-01)510(k)Apr 26, 2024Neurology |
| ClearPointer Optical Navigation Wand510(k)Jan 12, 2024Neurology |
| SmartFrame OR510(k)Jan 12, 2024Neurology |
| ClearPoint Bone Screw Fiducials510(k)Jan 12, 2024Neurology |
| ClearPoint System (Software Version 2.2)510(k)Nov 27, 2023Neurology |
| ClearPoint Array System (Version 1.2)510(k)Sep 15, 2023Neurology |
| ClearPoint System510(k)Sep 16, 2022Neurology |
| ClearPoint Maestro Brain Model510(k)Aug 8, 2022Radiology |
| ClearPoint Array System (version 1.1)510(k)Apr 12, 2022Neurology |
| ClearPoint Array System510(k)Jan 22, 2021Neurology |