Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Neurology ×
196 results for "medtronic"
1–24 of 196
Search insights Median review: 89d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 26, 2026
Stealth AXiS Cranial clinical application
K253379 · HAW
Medtronic Navigation, Inc.
Neurology · 177d
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · ONO
Medtronic Navigation, Inc.
Neurology · 164d
Cleared May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · ONO
Medtronic Navigation
Neurology · 115d
Cleared Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
K243676 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW
Medtronic Navigation, Inc.
Neurology · 108d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Medtronic Navigation, Inc.
Neurology · 58d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Dec 22, 2021
StealthStation S8 Cranial v2.0
K212397 · HAW
Medtronic Navigation
Neurology · 142d
Cleared Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm,...
K213454 · HBE
Medtronic Powered Surgical Solutions
Neurology · 28d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641 · JXG
Medtronic Neurosurgery
Neurology · 27d
Not Cleared Aug 23, 2021
SureTune4 Software
DEN210003 · QQC
Medtronic Neuromodulation
Neurology · 201d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Medtronic Navigation, Inc.
Neurology · 30d
Cleared Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
K200759 · GWF
Medtronic Xomed, Inc.
Neurology · 218d
Cleared Jun 03, 2020
StealthStation Cranial Software v1.3.0
K201175 · HAW
Medtronic Navigation, Inc.
Neurology · 33d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level,...
K201118 · GWM
Medtronic, Inc.
Neurology · 29d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Medtronic Navigation, Inc.
Neurology · 137d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Medtronic Navigation, Inc.
Neurology · 138d
Cleared May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515 · HBC
Medtronic Powered Surgical Solutions
Neurology · 145d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · LLZ
Medtronic Navigation, Inc.
Neurology · 237d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d