| 2025-01-24 |
K243657 |
ClearPoint System (Software Version 3.0) |
HAW |
— |
— |
| 2024-11-13 |
DEN240023 |
SmartFlow Neuro Cannula |
SDG |
Class II |
Neurology |
| 2024-04-26 |
K233703 |
Bone Anchor (NGS-BA-01) |
HAW |
— |
— |
| 2024-01-12 |
K233155 |
ClearPointer Optical Navigation Wand |
HAW |
— |
— |
| 2024-01-12 |
K233144 |
ClearPoint Bone Screw Fiducials |
HAW |
— |
— |
| 2024-01-12 |
K233141 |
SmartFrame OR |
HAW |
— |
— |
| 2023-11-27 |
K233243 |
ClearPoint System (Software Version 2.2) |
HAW |
— |
— |
| 2023-09-15 |
K232102 |
ClearPoint Array System (Version 1.2) |
HAW |
— |
— |
| 2022-09-16 |
K222519 |
ClearPoint System |
HAW |
— |
— |
| 2022-08-08 |
K213645 |
ClearPoint Maestro Brain Model |
QIH |
Class II |
Radiology |
| 2022-04-12 |
K214040 |
ClearPoint Array System (version 1.1) |
HAW |
— |
— |
| 2021-01-22 |
K202575 |
ClearPoint Array System |
HAW |
— |
— |