Company · US
Medtronic Navigation, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (4 in 12 months)
113recalls (4 in 12 months)
109recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 86 |
| OLO | Orthopedic Stereotaxic Instrument | 26 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 14 |
| GEX | Powered Laser Surgical Instrument | 5 |
| LLZ | System, Image Processing, Radiological | 4 |
| ONO | Neurosurgical Laser With Mr Thermography | 4 |
| IZL | System, X-Ray, Mobile | 3 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 3 |
| GAH | Stylet, Surgical, General & Plastic Surgery | 2 |
| GXY | Electrode, Cutaneous | 2 |
| OWB | Interventional Fluoroscopic X-Ray System | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| GAD | Retractor | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| JZL | 1 | |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2026 | K253379 | Stealth AXiS Cranial clinical application Medtronic Navigation, Inc. | HAW |
| Mar 16, 2026 | K253395 | Stealth AXiS ENT clinical application Medtronic Navigation, Inc. | PGW |
| Mar 13, 2026 | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Medtronic Navigation, Inc. | ONO |
| Feb 12, 2026 | K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical application Medtronic Navigation, Inc. | OLO |
| Oct 17, 2025 | K251282 | StealthStation S8 Spine Software Medtronic Navigation, Inc. | OLO |
| Jun 5, 2025 | K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts Medtronic Navigation, Inc. | OLO |
| May 29, 2025 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) Medtronic Navigation | ONO |
| Jun 21, 2024 | K240465 | O-arm O2 Imaging System Medtronic Navigation, Inc. | OWB |
| Oct 19, 2023 | K231976 | StealthStation Cranial Software, v3.1.5 (9735585) Medtronic Navigation, Inc. | HAW |
| Jun 10, 2022 | K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 Medtronic Navigation, Inc. | HAW |
| Jan 7, 2022 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) Medtronic Navigation, Inc. | ONO |
| Dec 22, 2021 | K212397 | StealthStation S8 Cranial v2.0 Medtronic Navigation | HAW |
| Jul 8, 2021 | K211442 | StealthStation Spinous Process Clamps Medtronic Navigation | OLO |
| Jan 13, 2021 | K203639 | StealthStation Cranial Software v1.3.2 Medtronic Navigation, Inc. | HAW |
| Jun 26, 2020 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) Medtronic Navigation, Inc. | PGW |
| Jun 18, 2020 | K201327 | NavLock Trackers Medtronic Navigation | OLO |
| Jun 3, 2020 | K201175 | StealthStation Cranial Software v1.3.0 Medtronic Navigation, Inc. | HAW |
| May 29, 2020 | K201189 | Stealthstation S8 Spine Software v1.3.0 Medtronic Navigation, Inc. | OLO |
| Mar 24, 2020 | K193579 | PlasmaBlade X 3.0S LIGHT Medtronic Navigation | GEI |
| Nov 1, 2019 | K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System Medtronic Navigation, Inc. | HAW |
| Jul 31, 2019 | K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Medtronic Navigation, Inc. | HAW |
| Mar 6, 2019 | K181859 | Visualase Thermal Therapy System Medtronic Navigation, Inc. | LLZ |
| Nov 2, 2018 | K182104 | NavLock Trackers, Robotic Reference Frame Medtronic Navigation | OLO |
| Jul 11, 2018 | K180816 | Ziehm RFD 3D Tracker Medtronic Navigation | OLO |
| Jul 3, 2017 | K171267 | NavLock Trackers Medtronic Navigation | OLO |
| May 19, 2017 | K170018 | StealthStationTM S8 ENT Software Medtronic Navigation, Inc. | PGW |
| May 1, 2017 | K170011 | StealthStation S8 Spine Software v1.0.0 Medtronic Navigation | OLO |
| Apr 21, 2017 | K162655 | StealthConnect Remote Viewing, Planning and Collaboration System Medtronic Navigation, Inc. | HAW |
| Mar 31, 2017 | K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software Medtronic Navigation, Inc. | HAW |
| Dec 30, 2016 | K162604 | Cranial Reducing Tubes Medtronic Navigation, Inc. | HAW |
| Sep 14, 2016 | K153660 | StealthStation System with Cranial Software Medtronic Navigation, Inc. | HAW |
| Apr 7, 2016 | K153555 | EM ENT Navigated Suctions Medtronic Navigation, Inc. | PGW |
| Feb 18, 2016 | K153247 | Fusion Compact Navigation System Medtronic Navigation, Inc. | PGW |
| Jun 11, 2015 | K150216 | Synergy Cranial Medtronic Navigation, Inc. | HAW |
| Mar 25, 2015 | K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION Medtronic Navigation, Inc. | HAW |
| Jul 25, 2014 | K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM Medtronic Navigation, Inc. | HAW |
| Mar 13, 2014 | K133665 | MALLEABLE SUCTION INSTRUMENTS Medtronic Navigation, Inc. | PGW |
| Aug 14, 2013 | K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER Medtronic Navigation, Inc. | OLO |
| Aug 7, 2013 | K130608 | QUADCUT Medtronic Navigation, Inc. | HAW |
| Mar 22, 2013 | K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS Medtronic Navigation, Inc. | OLO |
| Jul 18, 2008 | K081512 | STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE Medtronic Navigation, Inc. | LLZ |
| Aug 31, 2006 | K061248 | AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Navigation, Inc. | HAW |
| Mar 2, 2006 | K052623 | IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Navigation, Inc. | HAW |
| Jul 27, 2005 | K050651 | MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION Medtronic Navigation, Inc. | HAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Jan 27, 2025 | Medtronic Navigation, Inc. Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235
Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236
The Sterile Percutaneous Reference Pin Set is intended to be used to place and remove Open, Classified |
OLO | K131425 |
| Oct 10, 2024 | Medtronic Navigation, Inc. StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762)
The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in Open, Classified |
OLO | K201189 |
| 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 |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | K131425 |
| Jan 10, 2024 | Medtronic Navigation, Inc. Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS Open, Classified |
OLO | K131425 |
| 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 |
| Jan 30, 2023 | Medtronic Navigation, Inc. AxiEM" Non-Invasive Patient Tracker Open, Classified |
HAW | K141833 |
| Jan 12, 2023 | Medtronic Navigation, Inc. RadiaLux Lighted Retractor (Pink), REF: 50-101-1 Open, Classified |
GAD | None listed |
| Nov 17, 2022 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE
FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures. Open, Classified |
ONO | K053087 K181859 +1 |
| 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 |
| Jun 9, 2020 | Medtronic Navigation, Inc. Mazor X Surgical System Positioner Type II, REF: ASM0214-02 Open, Classified |
OLO | K182077 |
| 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 10, 2020 | Medtronic Navigation, Inc. NavLock Tracker *** Rx Only Terminated |
OLO | K171267 K182104 |
| 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 |
| Jul 8, 2019 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System Tubing Set kits
Product numbers:
VCLAS 9735559, 3mm tip/1.65mm catheter
VCLAS 9735560, 10mm tip/1.65mm catheter
VCLAS 9735561, 15mm tip/1.85mm catheter Terminated |
GEX | K071328 |
| 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 |
| Dec 6, 2018 | Medtronic Navigation, Inc. Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 0064 Terminated |
OLO | K131425 |
| Jun 1, 2018 | Medtronic Navigation, Inc. Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 Terminated |
LLZ | K081656 |
| Mar 23, 2018 | Medtronic Navigation, Inc. Visualase Cooled Laser Applicator System (VCLAS) labeled as:
a. Part Number 9735559, Visualase Cooled Laser Applicator System 3mm Tip;
b. Part Number 9735560 Visualase Cooled Laser Applicator Sys Terminated |
GEX | K053087 |
| Jul 27, 2017 | Medtronic Navigation, Inc. VCLAS (Visualase Cooled Laser Ablation System)
Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;
Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;
Part N Terminated |
GEX | K053087 |
| Jul 3, 2017 | Medtronic Navigation, Inc. Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Terminated |
GEX | K053087 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intende Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigi Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Short
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attac Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Spine Referencing Instrumentation, Spinous Process Clamp, Tall
When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attach Terminated |
OLO | K131425 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
Th Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). T Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrument Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrume Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrumen Terminated |
PGW | K153555 |
| Jun 29, 2017 | Medtronic Navigation, Inc. Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO.
The suction devices are part of a family of reusable ENT instrument Terminated |
PGW | K153555 |
| Jun 26, 2017 | Medtronic Navigation, Inc. Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Terminated |
HAW | K050438 |
| Jan 11, 2017 | Medtronic Navigation, Inc. AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton. Terminated |
HAW | K141833 |
| Oct 28, 2016 | Medtronic Navigation, Inc. Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box wh Terminated |
GAH | None listed |
| Oct 28, 2016 | Medtronic Navigation, Inc. Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box Terminated |
GAH | None listed |
| Jul 18, 2016 | Medtronic Navigation, Inc. MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as a Terminated |
HAW | K001284 |
| Jul 18, 2016 | Medtronic Navigation, Inc. MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes.
Product Usage:
The StealthStation System is intended as an aid Terminated |
HAW | K050438 |
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