Medical Device Manufacturer · US , Lafayette , CO

Medtronic Navigation, Inc. - FDA 510(k) Cleared Devices

34 submissions · 34 cleared · Since 2005
34
Total
34
Cleared
0
Denied

FDA 510(k) cleared devices by Medtronic Navigation, Inc. Neurology

20 devices
1-20 of 20
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · ONO
Neurology · 164d
Cleared Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW
Neurology · 108d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Neurology · 58d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO
Neurology · 255d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Neurology · 30d
Cleared Jun 03, 2020
StealthStation Cranial Software v1.3.0
K201175 · HAW
Neurology · 33d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Neurology · 137d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Neurology · 138d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · LLZ
Neurology · 237d
Cleared Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW
Neurology · 210d
Cleared Mar 31, 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · HAW
Neurology · 226d
Cleared Dec 30, 2016
Cranial Reducing Tubes
K162604 · HAW
Neurology · 102d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · HAW
Neurology · 268d
Cleared Jun 11, 2015
Synergy Cranial
K150216 · HAW
Neurology · 132d
Cleared Mar 25, 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER,...
K141833 · HAW
Neurology · 261d
Cleared Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · HAW
Neurology · 255d
Cleared Aug 07, 2013
QUADCUT
K130608 · HAW
Neurology · 153d
Cleared Aug 31, 2006
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K061248 · HAW
Neurology · 120d
Cleared Mar 02, 2006
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM
K052623 · HAW
Neurology · 160d
Cleared Jul 27, 2005
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION
K050651 · HAW
Neurology · 135d
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