Neurological Stereotaxic Instrument
Regulation 882.4560
5510(k)s in 12 months (426 all time)
8recalls in 12 months (202 all time)
199recalls that name a 510(k)
Top companies in HAW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Stryker Leibinger GmbH & Co. KG Precision Pointer Electromagnetic (8000-050-001) Open, Classified |
HAW | K212194 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly Open, Classified |
HAW | K971247 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly Open, Classified |
HAW | K033621 |
| Apr 29, 2026 | Elekta, Inc. Brand Name: Leksell Vantage Arc System
REF: 1053958 Open, Classified |
HAW | K190887 |
| Dec 19, 2025 | Howmedica Osteonics Corp. The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit fo Open, Classified |
HAW | K212194 |
| Nov 5, 2025 | Elekta, Inc. Brand Name: Leksell Stereotactic System
Product Name: Leksell Vantage Stereotactic System
Software Version: n/a
Product Description: The Intended Purpose of Leksell Vantage" Stereotactic System is tar Open, Classified |
HAW | K190887 |
| Nov 8, 2024 | FHC, Inc. microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedure Open, Classified |
HAW | K011775 |
| Nov 6, 2024 | Elekta Instrument AB Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933,
Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic Open, Classified |
HAW | K152558 |
| May 9, 2024 | Medtronic Navigation, Inc. Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or
percutaneous neurosurgical pr Open, Classified |
HAW | K162309 |
| Apr 16, 2024 | Elekta Instrument AB Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereo Open, Classified |
HAW | K152558 |
| Apr 4, 2024 | Navinetics Inc NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 Open, Classified |
HAW | K231392 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1870S Open, Classified |
HAW | K200047 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref: 6143.1842S Open, Classified |
HAW | K200047 |
| Feb 6, 2024 | Globus Medical, Inc. Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS.
Ref : 6143.1834S Open, Classified |
HAW | K200047 |
| Nov 10, 2023 | Medtronic Navigation, Inc. StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762)
The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either Open, Classified |
HAW | K212397 |
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Open, Classified |
HAW | K150216 K153660 +2 |
| Jun 2, 2023 | Medtronic Navigation, Inc. StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Open, Classified |
HAW | K221087 |
| Mar 30, 2023 | Elekta Instrument AB Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments:
(1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III;
(2) Part #A2800-15, Backlund Open, Classified |
HAW | K152558 |
| Jan 30, 2023 | Medtronic Navigation, Inc. AxiEM" Non-Invasive Patient Tracker Open, Classified |
HAW | K141833 |
| Nov 11, 2021 | Medtronic Navigation, Inc. Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software.
Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585 Open, Classified |
HAW | K150216 K190672 |
| Nov 9, 2021 | Medtronic Navigation, Inc. Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit. Open, Classified |
HAW | K191597 |
| Oct 21, 2021 | Medtronic Xomed, Inc. Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following produ Open, Classified |
HAW | K130608 |
| Sep 22, 2021 | MEDTECH SAS ROSA One 3.1 Brain application
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instr Open, Classified |
HAW | K182417 K200511 |
| Aug 31, 2020 | Brainlab AG Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system t Terminated |
HAW | K092467 |
| Jun 10, 2020 | Elekta Instrument AB Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 Terminated |
HAW | K171123 |
| Jun 5, 2020 | Medtronic Navigation, Inc. StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous proced Terminated |
HAW | K133444 |
| May 18, 2020 | Medtronic Navigation, Inc. Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imagin Terminated |
HAW | K153660 K162309 |
| Apr 29, 2020 | Elekta Inc Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument Terminated |
HAW | K171123 K190887 |
| Jan 6, 2020 | MEDTECH SAS ROSA One 3.1 Brain Application Terminated |
HAW | K151359 K172444 +1 |
| Jan 6, 2020 | MEDTECH SAS ROSA Brain 3.0 Application-Brain Terminated |
HAW | K151359 K172444 +1 |
| Nov 1, 2019 | MEDTECH SAS Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped steril Terminated |
HAW | K151359 K172444 |
| Oct 30, 2019 | Medtronic Navigation, Inc. Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 Open, Classified |
HAW | K971247 |
| Oct 30, 2019 | Medtronic Navigation, Inc. Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 Open, Classified |
HAW | K971247 |
| Oct 30, 2019 | Medtronic Navigation, Inc. Passive Biopsy Needle Kit, UDI: 00643169030121
and 00643169702943 Open, Classified |
HAW | K971247 |
| Apr 15, 2019 | Brainlab AG Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )
Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image Terminated |
HAW | K070106 |
| Dec 29, 2018 | Medtronic Navigation, Inc. StealthStation Cranial and Synergy Cranial Depth Gauge:
StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3. Terminated |
HAW | K150216 K153660 |
| Nov 26, 2018 | Synaptive Medical Inc BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2
Product Usage:
BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Terminated |
HAW | K153281 |
| May 10, 2018 | FHC, Inc. microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8), Terminated |
HAW | K011992 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002 Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001 Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System Distributed by Medtronic, Product Number FC1006 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" Lead Adapter
for microTargeting" Drive, Product Number 66-CN-DB Terminated |
HAW | K011992 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number 70-ZD-ME Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number 70-ZD-MA Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Motorized), Product Number ST-DS-ME Terminated |
HAW | K092562 |
| May 10, 2018 | FHC, Inc. microTargeting" STar" Drive
System (Manual), Product Number ST-DS-MA Terminated |
HAW | K092562 |
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