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 ×
6,334 results
25–48 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 02, 2026
OAB Delivery Catheter
K253422 · QJP
Cognition Medical Corp.
Neurology · 366d
Cleared Sep 24, 2026
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
K263010 · GWF
Inomed Medizintechnik GmbH
Neurology · 27d
Cleared Sep 17, 2026
Durashield Device Kit
K252995 · GZT
SurGenTec, LLC
Neurology · 364d
Cleared Sep 16, 2026
Ceribell EEG Analysis Software
K261712 · OLT
Ceribell, Inc.
Neurology · 117d
Cleared Sep 16, 2026
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
K261370 · NFO
Guangdong Newdermo Biotech Co., Ltd.
Neurology · 142d
Cleared Sep 16, 2026
Route 92 Medical Full Length 046 Access System
K260220 · QJP
Route 92 Medical, Inc.
Neurology · 233d
Cleared Sep 16, 2026
Aristotle 65 Macrowire
K254181 · MOF
Scientia Vascular
Neurology · 267d
Cleared Sep 15, 2026
Tontarra Punches and Rongeurs
K260446 · HAE
Tontarra Medizintechnik GmbH
Neurology · 216d
Cleared Sep 14, 2026
Radical 064 Reperfusion Catheter
K261089 · NRY
Maduro Medical, Inc.
Neurology · 166d
Cleared Sep 11, 2026
CraniUS Plate
K262874 · GWO
CraniUS, LLC
Neurology · 28d
Cleared Sep 11, 2026
PureLift Pro Max
K262861 · NFO
Xtreem Pulse, LLC
Neurology · 29d
Cleared Sep 11, 2026
Disposable Sterile Skull Drill (LZ)
K254177 · HBF
Guizhou Zirui Technology Co., Ltd.
Neurology · 262d
Cleared Sep 11, 2026
Surgical Power System
K254174 · HBC
Guizhou Zirui Technology Co., Ltd.
Neurology · 262d
Cleared Sep 10, 2026
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K253856 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 281d
Cleared Sep 06, 2026
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ,...
K261131 · NUH
Shenzhen Osto Medical Technology Co.,Ltd
Neurology · 153d
Cleared Sep 06, 2026
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100,...
K260396 · OBP
Fidelity BioPharma Co.
Neurology · 212d
Cleared Sep 04, 2026
70 NeuGlide Catheter
K262277 · QJP
Piraeus Medical, Inc.
Neurology · 60d
Cleared Sep 03, 2026
NeuroBlate System
K262315 · ONO
Monteris Medical,
Neurology · 57d
Cleared Sep 02, 2026
Trexo Theo
K254198 · PHL
Trexo Robotics, Inc.
Neurology · 253d
Cleared Aug 28, 2026
Zoom 4S Catheter
K261176 · QJP
Imperative Care, Inc.
Neurology · 140d
Cleared Aug 28, 2026
Tigertriever 13 Ultra Revascularization Device
K260617 · NRY
Rapid Medical , Ltd.
Neurology · 184d
Cleared Aug 27, 2026
Dexus Prosthetic System (MSL2, MSR2)
K262654 · GXY
Zhejiang Qiangnao Technology Co.,Ltd
Neurology · 28d
Cleared Aug 27, 2026
35 Helix Guidewire
K260751 · MOF
Piraeus Medical, Inc.
Neurology · 174d
Cleared Aug 26, 2026
StimTrial Neuromodulation System
K253877 · GZF
Bioventus, LLC
Neurology · 265d