| Leksell® Vantage Stereotactic System (K261932) | Elekta Solutions AB | 2026-08-05 |
| Zeta Navigation System (K253663) | Zeta Surgical, Inc. | 2026-05-01 |
| Stealth AXiS Cranial clinical application (K253379) | Medtronic Navigation, Inc. | 2026-03-26 |
| NeuroAlign software (K231897) | Medivis, Inc. | 2025-10-21 |
| SOLOPASS 2.0 System (K251317) | Intravent Medical Partners | 2025-09-05 |
| Ball Joint Guide Array (66295) (K250893) | Bayer Medical Care, Inc. | 2025-09-04 |
| EZ-FIDUCIALS (K250505) | Phasor Health, LLC | 2025-07-09 |
| Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) | Brain Navi Biotechnology Co., Ltd. | 2025-05-23 |
| Navient Image Guide Navigation System (955-NC-NC), Cranial (K241327) | Claronav | 2025-02-05 |
| Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT (K243698) | Brainlab AG | 2025-01-28 |
| ClearPoint System (Software Version 3.0) (K243657) | ClearPoint Neuro, Inc. | 2025-01-24 |
| Geniant Cranial (Navigated Neurosurgical Positioning Robot) (K241333) | Koh Young Technology, Inc. | 2025-01-17 |
| FLASH EVD System (10-0002) (K242480) | 7D Surgical ULC | 2024-12-27 |
| Zeta Cranial Navigation System (ZNS131-US) (K242351) | Zeta Surgical, Inc. | 2024-10-04 |
| Bone Anchor (NGS-BA-01) (K233703) | ClearPoint Neuro, Inc. | 2024-04-26 |
| ClearPoint Bone Screw Fiducials (K233144) | ClearPoint Neuro, Inc. | 2024-01-12 |
| ClearPointer Optical Navigation Wand (K233155) | ClearPoint Neuro, Inc. | 2024-01-12 |
| SmartFrame OR (K233141) | ClearPoint Neuro, Inc. | 2024-01-12 |
| Zeta Cranial Navigation System (ZNS131-US) (K233903) | Zeta Surgical, Inc. | 2024-01-10 |
| ClearPoint System (Software Version 2.2) (K233243) | ClearPoint Neuro, Inc. | 2023-11-27 |
| StealthStation Cranial Software, v3.1.5 (9735585) (K231976) | Medtronic Navigation, Inc. | 2023-10-19 |
| ClearPoint Array System (Version 1.2) (K232102) | ClearPoint Neuro, Inc. | 2023-09-15 |
| Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial (K223864) | Brainlab AG | 2023-09-09 |
| Zeta Cranial Navigation System (K230661) | Zeta Surgical | 2023-09-08 |
| Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (K223288) | Brainlab AG | 2023-07-21 |
| ROSA ONE Brain Application (K231103) | Medtech S.A.S | 2023-07-20 |
| NaviNetics Reusable Stereotactic System (NN1000) (K231392) | Navinetics, Inc. | 2023-07-14 |
| Sinobot X1 (K220072) | Sinovation (Beijing) Medical Technology Co., Ltd. | 2023-06-18 |
| Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial (K223552) | Brainlab AG | 2023-04-19 |
| Localite TMS Navigator TS (K223577) | Localite GmbH | 2023-04-17 |
| MagVenture TMS Atlas Neuro Navigation System (K221544) | Tonica Elektronik A/S | 2023-03-17 |
| Disposable Pre-calibrated Brain Biopsy Needle 2.0 (K230201) | PAJUNK GmbH Medizintechnologie | 2023-02-22 |
| Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System (K212194) | Stryker Corporation | 2023-02-16 |
| ClearPoint System (K222519) | ClearPoint Neuro, Inc. | 2022-09-16 |
| Cranial EM System (K213989) | Brainlab AG | 2022-09-08 |
| Disposable Brain Biopsy Needle 2.0 (K220897) | PAJUNK GmbH Medizintechnologie | 2022-08-17 |
| Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (K221087) | Medtronic Navigation, Inc. | 2022-06-10 |
| ROSA ONE Brain application (K214065) | Medtech S.A.S | 2022-05-04 |
| ClearPoint Array System (version 1.1) (K214040) | ClearPoint Neuro, Inc. | 2022-04-12 |
| visor2 system (K210109) | Eemagine Medical Imaging Solutions GmbH | 2022-04-08 |
| StealthStation S8 Cranial v2.0 (K212397) | Medtronic Navigation | 2021-12-22 |
| Molecular Flow Simulations (K201435) | Therataxis, LLC | 2021-12-03 |
| Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System (K210989) | Brainlab AG | 2021-11-12 |
| Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization (K211544) | Brainlab AG | 2021-11-03 |
| SOLOPASS System (K203251) | Intravent Medical Partners, LP | 2021-08-27 |
| NaviNetics D1 Stereotactic System (K210700) | Navinetics, Inc. | 2021-06-17 |
| Disposable Pre-calibrated Suction (K201752) | Brainlab AG | 2021-01-29 |
| ClearPoint Array System (K202575) | ClearPoint Neuro, Inc. | 2021-01-22 |
| StealthStation Cranial Software v1.3.2 (K203639) | Medtronic Navigation, Inc. | 2021-01-13 |
| Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (K192703) | Brainlab AG | 2020-10-08 |
| StealthStation Cranial Software v1.3.0 (K201175) | Medtronic Navigation, Inc. | 2020-06-03 |
| ROSA ONE Brain application (K200511) | Medtech S.A | 2020-05-29 |
| Neural Navigator (K191422) | Soterix Medical, Inc. | 2020-04-06 |
| ClearPoint System and Accessories (K200079) | Mri Interventions, Inc. | 2020-02-13 |
| 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application (K192945) | 7D Surgical, Inc. | 2019-11-27 |
| Stealth Autoguide System, Midas Rex Legend Depth Stop System (K191597) | Medtronic Navigation, Inc. | 2019-11-01 |
| Microscope Navigation (K190250) | Brainlab AG | 2019-09-06 |
| 7D Surgical System (K183276) | 7D Surgical, Inc. | 2019-08-07 |
| Leksell Vantage Stereotactic System (K190887) | Elekta Instrument AB | 2019-08-01 |
| StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 (K190672) | Medtronic Navigation, Inc. | 2019-07-31 |
| Modus Nav (K183325) | Synaptive Medical, Inc. | 2019-07-14 |
| Voyager Trajectory Array Guide (V-TAG) (K191400) | Mri Interventions, Inc. | 2019-06-21 |
| ROSA ONE Brain Application (K182417) | Medtech S.A | 2019-02-07 |
| AQrate Robotic Assistance System (K182000) | Globus Medical, Inc. | 2019-01-29 |
| 7D Surgical System Cranial Application (K181041) | 7D Surgical, Inc. | 2018-08-08 |
| neuromate Gen III (K181706) | Renishaw Mayfield Sarl | 2018-07-26 |
| Voyager Trajectory Array Guide (V-TAG) (K180854) | Voyager Therapeutics, Inc. | 2018-07-23 |
| neuromate Gen III (K180206) | Renishaw Mayfield Sarl | 2018-04-24 |
| ROSA BRAIN (v3.0.0.5) (K172444) | Medtech S.A | 2018-03-28 |
| Microscope Navigation Software (K172820) | Brainlab AG | 2018-03-01 |
| Leksell Vantage Stereotactic System (K171123) | Elekta Instrument AB | 2017-09-15 |
| neuro inspire (K163666) | Rensihaw Plc | 2017-09-15 |
| Fiagon Navigation System (K163209) | Fiagon GmbH | 2017-09-14 |
| NaviENT (K163439) | Claronav, Inc. | 2017-09-01 |
| StealthConnect Remote Viewing, Planning and Collaboration System (K162655) | Medtronic Navigation, Inc. | 2017-04-21 |
| StealthStation S8 System Platforms and StealthStation Cranial Software (K162309) | Medtronic Navigation, Inc. | 2017-03-31 |
| Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker (K162929) | Stryker Corporation | 2017-02-22 |
| Cranial Reducing Tubes (K162604) | Medtronic Navigation, Inc. | 2016-12-30 |
| CRW STEREOTACTIC SYSTEM (K160811) | Integra LifeSciences Corporation | 2016-12-06 |
| StealthStation System with Cranial Software (K153660) | Medtronic Navigation, Inc. | 2016-09-14 |
| EXACTECH GPS (K152764) | Blue Ortho | 2016-07-13 |
| BrightMatter Guide with BrightMatter Pointer (K160523) | Synaptive Medical, Inc. | 2016-06-24 |
| Fiagon Navigation System (K151156) | Fiagon GmbH | 2016-04-01 |
| BrightMatter Guide with Surface Trace Registration (K153281) | Synaptive Medical, Inc. | 2016-03-30 |
| ClearPoint System (K160434) | Mri Interventions, Inc. | 2016-03-17 |
| Leksell Stereotactic System, Injection/ Aspiration Needle Kit (K152558) | Elekta Instrument AB | 2016-03-02 |
| ROSA Brain (K151359) | Medtech S.A | 2015-12-18 |
| SYMBIS Surgical System (K143420) | Imris, Inc. | 2015-10-30 |
| ClearPoint System (K142505) | Mri Interventions, Inc. | 2015-10-21 |
| NavSuite3 Kit (K150301) | Stryker Leibinger GmbH & Co. KG - Navigation | 2015-07-08 |
| Synergy Cranial (K150216) | Medtronic Navigation, Inc. | 2015-06-11 |
| MDT Navigable Brain Biopsy Cannula (K143241) | Izi Medical Products, LLC | 2015-04-13 |
| BRIGHTMATTER NAVIGATION SYSTEM (K142024) | Synaptive Medical, Inc. | 2015-04-02 |
| STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833) | Medtronic Navigation, Inc. | 2015-03-25 |
| DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System (K142344) | Izi Medical Products, LLC | 2015-03-20 |
| V-GUIDE FOR VENTRICULOSTOMIES (K141559) | Arc Surgical, LLC | 2015-02-27 |
| NAVIGABLE BRAIN BIOPSY CANNULA SET (K140705) | Izi Medical Products | 2014-12-05 |
| STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM (K133444) | Medtronic Navigation, Inc. | 2014-07-25 |
| STRYKER KWIC NEEDLE (K140868) | Orthovita, Inc. | 2014-06-05 |
| NEUROMATE FRAMELESS GEN II (K132755) | Renishaw Mayfield Sarl | 2014-04-29 |