Medtronic Navigation, Inc
Lafayette, CO, US
MEDTRONIC NAVIGATION, INC. appears in FDA device records in Lafayette, CO. FDA records list 85 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 149 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to Medtronic Navigation, Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medtronic Advanced Energy, LLC510(k), enforcement report, recall
- MEDTRONIC NAVIGATION, INC. (Boxborough)registration, enforcement report, recall
- Medtronic Navigation, Inc. (Littleton)510(k), enforcement report, recall
- Medtronic Surgical Navigation Tech, Increcall
- Medtronic Surgical Navigation Technologies510(k), recall
- Odin Medical Technologies , Ltd.510(k), recall
- Tissuelink Medical, Inc.510(k), recall
510(k) clearance history
Showing 50 of 85FDA records hold 85 510(k) clearances for Medtronic Navigation, Inc between 2000 and 2026. The busiest year on record is 2002, with 8. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 4 |
| 2001 | 4 |
| 2002 | 8 |
| 2003 | 7 |
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 5 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 5 |
| 2017 | 8 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253379 | Stealth AXiS Cranial clinical application | HAW | Substantially Equivalent | |
| K253395 | Stealth AXiS™ ENT clinical application | PGW | Substantially Equivalent | |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) | ONO | Substantially Equivalent | |
| K253381 | Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application | OLO | Substantially Equivalent | |
| K251282 | StealthStation S8 Spine Software | OLO | Substantially Equivalent | |
| K242464 | Stealth™ Spine Clamps; ModuLeX™ Shank Mounts | OLO | Substantially Equivalent | |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | ONO | Substantially Equivalent | |
| K240465 | O-arm O2 Imaging System | OWB | Substantially Equivalent | |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | HAW | Substantially Equivalent | |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | HAW | Substantially Equivalent | |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | ONO | Substantially Equivalent | |
| K212397 | StealthStation S8 Cranial v2.0 | HAW | Substantially Equivalent | |
| K211442 | StealthStation Spinous Process Clamps | OLO | Substantially Equivalent | |
| K203639 | StealthStation Cranial Software v1.3.2 | HAW | Substantially Equivalent | |
| K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | Substantially Equivalent | |
| K201327 | NavLock Trackers | OLO | Substantially Equivalent | |
| K201175 | StealthStation Cranial Software v1.3.0 | HAW | Substantially Equivalent | |
| K201189 | Stealthstation S8 Spine Software v1.3.0 | OLO | Substantially Equivalent | |
| K193579 | PlasmaBlade X 3.0S LIGHT | GEI | Substantially Equivalent | |
| K191597 | Stealth Autoguide System, Midas Rex Legend Depth Stop System | HAW | Substantially Equivalent | |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | HAW | Substantially Equivalent | |
| K183129 | Medtronic Total Hip Arthroplasty System | LPH | Substantially Equivalent | |
| K181859 | Visualase Thermal Therapy System | LLZ | Substantially Equivalent | |
| K182104 | NavLock Trackers, Robotic Reference Frame | OLO | Substantially Equivalent | |
| K181257 | PlasmaBlade X 3.0S, PlasmaBlade X 4.0 | GEI | Substantially Equivalent | |
| K180816 | Ziehm RFD 3D Tracker | OLO | Substantially Equivalent | |
| K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | GEI | Substantially Equivalent | |
| K171267 | NavLock Trackers | OLO | Substantially Equivalent | |
| K170018 | StealthStationTM S8 ENT Software | PGW | Substantially Equivalent | |
| K170011 | StealthStation S8 Spine Software v1.0.0 | OLO | Substantially Equivalent | |
| K162655 | StealthConnect Remote Viewing, Planning and Collaboration System | HAW | Substantially Equivalent | |
| K170610 | PlasmaBlade T | GEI | Substantially Equivalent | |
| K162309 | StealthStation S8 System Platforms and StealthStation Cranial Software | HAW | Substantially Equivalent | |
| K170296 | CoreCath 2.7S | GEI | Substantially Equivalent | |
| K162604 | Cranial Reducing Tubes | HAW | Substantially Equivalent | |
| K153660 | StealthStation System with Cranial Software | HAW | Substantially Equivalent | |
| K152703 | PlasmaBlade TnA Tonsil and Adenoid Dissection Device | GEI | Substantially Equivalent | |
| K153555 | EM ENT Navigated Suctions | PGW | Substantially Equivalent | |
| K153247 | Fusion Compact Navigation System | PGW | Substantially Equivalent | |
| K150216 | Synergy Cranial | HAW | Substantially Equivalent | |
| K150297 | PlasmaBlade UPPP and Suction Coagulator | GEI | Substantially Equivalent | |
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION | HAW | Substantially Equivalent | |
| K143175 | AEx Generator; PlasmaBlade T | GEI | Substantially Equivalent | |
| K133444 | STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM | HAW | Substantially Equivalent | |
| K133665 | MALLEABLE SUCTION INSTRUMENTS | PGW | Substantially Equivalent | |
| K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | Substantially Equivalent | |
| K131425 | NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER | OLO | Substantially Equivalent | |
| K130608 | QUADCUT | HAW | Substantially Equivalent | |
| K124004 | NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS | OLO | Substantially Equivalent | |
| K123201 | AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1723170 | 1000517638 | MEDTRONIC NAVIGATION, INC. | 200 Medtronic Drive, Lafayette, CO 80026 US | 2026 | and 15 more, listed in full below |
| 3004785967 | 3004785967 | MEDTRONIC NAVIGATION, INC. (Boxborough) | 200 Beaver Brook Rd, Boxborough, MA 01719 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- MOSCoil, Magnetic Resonance, Specialty
- DQKComputer, Diagnostic, Programmable
- PUIDrape, Surgical, Exempt
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- PGWEar, Nose, And Throat Stereotaxic Instrument
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FZYHammer, Surgical
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile
- MDMInstrument, Manual, Surgical, General Use
- HAOInstrument, Surgical, Non-Powered
- OWBInterventional Fluoroscopic X-Ray System
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- HBCMotor, Drill, Electric
- HBBMotor, Drill, Pneumatic
- HAWNeurological Stereotaxic Instrument
- ONONeurosurgical Laser With Mr Thermography
- OLOOrthopedic Stereotaxic Instrument
- GEXPowered Laser Surgical Instrument
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- FRNPump, Infusion
- GADRetractor
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GAHStylet, Surgical, General & Plastic Surgery
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- FRGWrap, Sterilization
Recall records
Showing 25 of 149| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2451-2026 | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. | Class II | Open, Classified | |
| Z-2101-2025 | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture. | Class II | Open, Classified | |
| Z-1022-2025 | 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 a pin percutaneously into bony patient anatomy for rigid attachment of a patient reference during image-guided surgeries using a Medtronic computer-assisted surgery system. | Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. | Class II | Open, Classified | |
| Z-0050-2025 | 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 either open or percutaneous neurosurgical and orthopedic procedures. | Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal. | Class II | Open, Classified | |
| Z-2026-2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000 | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance. | Class II | Open, Classified | |
| Z-1776-2024 | 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 procedures. | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation. | Class I | Open, Classified | |
| Z-0699-2024 | Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS | Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. | Class II | Open, Classified | |
| Z-0698-2024 | Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS | Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove. | Class II | Open, Classified | |
| Z-0188-2024 | 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 or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is intended as an aid for locating anatomical structures in either open or percutaneous ENT procedures. | Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. | Class I | Open, Classified | |
| Z-2449-2023 | The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. | Ground cable installed incorrectly. | Class II | Open, Classified | |
| Z-1666-2023 | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance to/past target text no longer synchronized with navigation information, inaccurate value displayed; may result in prolonged/additional procedure, tissue injury | Class I | Open, Classified | |
| Z-1630-2023 | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values, which may result in prolonged/additional procedure, tissue injury | Class I | Open, Classified | |
| Z-1039-2023 | AxiEM" Non-Invasive Patient Tracker | Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery. | Class II | Open, Classified | |
| Z-0953-2023 | RadiaLux Lighted Retractor (Pink), REF: 50-101-1 | Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection. | Class II | Open, Classified | |
| Z-0244-2023 | 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. | Due to a defect in the outer pouch sterile seal | Class II | Open, Classified | |
| Z-0383-2022 | 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 | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may result in prolonged procedure, the need for additional surgical procedure, tissue injury. | Class I | Open, Classified | |
| Z-0417-2022 | Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit. | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA. | Class II | Open, Classified | |
| Z-2707-2020 | 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 procedures. | There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or illnesses have been reported, If impacted cameras were to be used with both active and passive trackers simultaneously, it would result in system navigation inaccuracy of 6mm. | Class II | Terminated | |
| Z-2330-2020 | Mazor X Surgical System Positioner Type II, REF: ASM0214-02 | There is a potential for the surgical system to detach from the operational room table unexpectedly. This could result in the surgical system falling onto the patient resulting in blunt injury [hemorrhage, hematoma, bleeding, or fracture(s)] | Class II | Open, Classified | |
| Z-0767-2020 | O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 | Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient. | Class II | Terminated | |
| Z-0659-2020 | Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery. | Class II | Open, Classified | |
| Z-0658-2020 | Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery. | Class II | Open, Classified | |
| Z-0657-2020 | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery. | Class II | Open, Classified | |
| Z-1693-2020 | NavLock Tracker *** Rx Only | Product was incorrectly assembled which could affect navigation accuracy of the device. | Class II | Terminated | |
| Z-1995-2020 | 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 Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument. | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging). | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain