Medical Device Manufacturer · US , Lafayette , CO

Medtronic Navigation, Inc.

33 submissions · 33 cleared · Since 2005
33
Total
33
Cleared
0
Denied

Medtronic Navigation, Inc. — FDA 510(k) Submissions

Medtronic Navigation, Inc. has submitted 33 FDA 510(k) premarket notifications since 2005, of which 33 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Neurological Stereotaxic Instrument, Orthopedic Stereotaxic Instrument, Ear, Nose, And Throat Stereotaxic Instrument, System, Image Processing, Radiological, Neurosurgical Laser With Mr Thermography . Use the specialty filter in the sidebar to narrow results.

33 devices
1–25 of 33
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
K253391 · ONO Neurosurgical Laser With... · Neurology
Mar 2026 164d
Stealth AXiS? Surgical System with Stealth AXiS? Spine clinical application
K253381 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2026 135d
StealthStation S8 Spine Software
K251282 · OLO Orthopedic Stereotaxic... · Orthopedic
Oct 2025 176d
Stealth? Spine Clamps; ModuLeX? Shank Mounts
K242464 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2025 290d
O-arm O2 Imaging System
K240465 · OWB Interventional... · Radiology
Jun 2024 126d
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW Neurological Stereotaxic... · Neurology
Oct 2023 108d
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW Neurological Stereotaxic... · Neurology
Jun 2022 58d
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO Neurosurgical Laser With... · Neurology
Jan 2022 255d
StealthStation Cranial Software v1.3.2
K203639 · HAW Neurological Stereotaxic... · Neurology
Jan 2021 30d
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Jun 2020 99d
StealthStation Cranial Software v1.3.0
K201175 · HAW Neurological Stereotaxic... · Neurology
Jun 2020 33d
Stealthstation S8 Spine Software v1.3.0
K201189 · OLO Orthopedic Stereotaxic... · Orthopedic
May 2020 28d
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW Neurological Stereotaxic... · Neurology
Nov 2019 137d
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
K190672 · HAW Neurological Stereotaxic... · Neurology
Jul 2019 138d
Visualase Thermal Therapy System
K181859 · LLZ System, Image Processing,... · Neurology
Mar 2019 237d
StealthStationTM S8 ENT Software
K170018 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
May 2017 136d
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW Neurological Stereotaxic... · Neurology
Apr 2017 210d
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · HAW Neurological Stereotaxic... · Neurology
Mar 2017 226d
Cranial Reducing Tubes
K162604 · HAW Neurological Stereotaxic... · Neurology
Dec 2016 102d
StealthStation System with Cranial Software
K153660 · HAW Neurological Stereotaxic... · Neurology
Sep 2016 268d
EM ENT Navigated Suctions
K153555 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Apr 2016 115d
Fusion Compact Navigation System
K153247 · PGW Ear, Nose, And Throat... · Ear, Nose, Throat
Feb 2016 101d
Synergy Cranial
K150216 · HAW Neurological Stereotaxic... · Neurology
Jun 2015 132d
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · HAW Neurological Stereotaxic... · Neurology
Mar 2015 261d
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW Neurological Stereotaxic... · Neurology
Jul 2014 255d
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