ClearanceBrief
Panels › Neurology › Product code HAW · Class 2

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)
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Top companies in HAW

DateFirm and productCodeLinked 510(k)
Oct 29, 2026Stryker Leibinger GmbH & Co. KG
Precision Pointer Electromagnetic (8000-050-001)
Open, Classified
HAWK212194
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Open, Classified
HAWK971247
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Open, Classified
HAWK033621
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Open, Classified
HAWK033621
Oct 16, 2026Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Open, Classified
HAWK033621
Apr 29, 2026Elekta, Inc.
Brand Name: Leksell Vantage Arc System REF: 1053958
Open, Classified
HAWK190887
Dec 19, 2025Howmedica 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
HAWK212194
Nov 5, 2025Elekta, 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
HAWK190887
Nov 8, 2024FHC, 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
HAWK011775
Nov 6, 2024Elekta 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
HAWK152558
May 9, 2024Medtronic 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
HAWK162309
Apr 16, 2024Elekta 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
HAWK152558
Apr 4, 2024Navinetics Inc
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
Open, Classified
HAWK231392
Feb 6, 2024Globus 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
HAWK200047
Feb 6, 2024Globus 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
HAWK200047
Feb 6, 2024Globus 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
HAWK200047
Nov 10, 2023Medtronic 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
HAWK212397
Jun 2, 2023Medtronic Navigation, Inc.
StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Open, Classified
HAWK150216
K153660 +2
Jun 2, 2023Medtronic Navigation, Inc.
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Open, Classified
HAWK221087
Mar 30, 2023Elekta 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
HAWK152558
Jan 30, 2023Medtronic Navigation, Inc.
AxiEM" Non-Invasive Patient Tracker
Open, Classified
HAWK141833
Nov 11, 2021Medtronic 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
HAWK150216
K190672
Nov 9, 2021Medtronic 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
HAWK191597
Oct 21, 2021Medtronic 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
HAWK130608
Sep 22, 2021MEDTECH 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
HAWK182417
K200511
Aug 31, 2020Brainlab 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
HAWK092467
Jun 10, 2020Elekta Instrument AB
Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887
Terminated
HAWK171123
Jun 5, 2020Medtronic 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
HAWK133444
May 18, 2020Medtronic 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
HAWK153660
K162309
Apr 29, 2020Elekta Inc
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Terminated
HAWK171123
K190887
Jan 6, 2020MEDTECH SAS
ROSA One 3.1 Brain Application
Terminated
HAWK151359
K172444 +1
Jan 6, 2020MEDTECH SAS
ROSA Brain 3.0 Application-Brain
Terminated
HAWK151359
K172444 +1
Nov 1, 2019MEDTECH 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
HAWK151359
K172444
Oct 30, 2019Medtronic Navigation, Inc.
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
Open, Classified
HAWK971247
Oct 30, 2019Medtronic Navigation, Inc.
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
Open, Classified
HAWK971247
Oct 30, 2019Medtronic Navigation, Inc.
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Open, Classified
HAWK971247
Apr 15, 2019Brainlab 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
HAWK070106
Dec 29, 2018Medtronic 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
HAWK150216
K153660
Nov 26, 2018Synaptive 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
HAWK153281
May 10, 2018FHC, Inc.
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
Terminated
HAWK011992
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Terminated
HAWK011775
May 10, 2018FHC, Inc.
microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
Terminated
HAWK011775
May 10, 2018FHC, Inc.
microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
Terminated
HAWK011992
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
Terminated
HAWK092562
May 10, 2018FHC, Inc.
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
Terminated
HAWK092562

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