FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
25–48 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jul 29, 2026
CraniUS Plate
K261058 · GWO
CraniUS, LLC
Neurology · 120d
Cleared Jul 26, 2026
Corsano CardioWatch 287-2 System
K261367 · MSX
Corsano Health B.V.
Neurology · 90d
Cleared Jul 23, 2026
FACEGYM Pro Device (HD-109)
K253932 · NFO
Shenzhen Kaiyan Medical Equipment...
Neurology · 226d
Cleared Jul 22, 2026
STEDI Scan Device
K253840 · QAF
Stroke DX
Neurology · 233d
Cleared Jul 21, 2026
Raney Clips Kit
K253814 · HBO
Beijing Honghugaoxiang Science and...
Neurology · 235d
Cleared Jul 17, 2026
Drivewire 35 Guidewire
K254006 · MOF
Rapid Medical , Ltd.
Neurology · 214d
Cleared Jul 16, 2026
Socrates Aspiration System (Socrates 70 Aspiration Catheter)
K260002 · NRY
Scientia Vascular, Inc.
Neurology · 195d
Cleared Jul 15, 2026
WRAP System
K260050 · MNR
Huneo, LLC
Neurology · 189d
Cleared Jul 14, 2026
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US,...
K260578 · GXY
Ambu A/S
Neurology · 144d
Cleared Jul 13, 2026
SLIM Microcatheter
K260199 · QJP
Balt USA, LLC
Neurology · 172d
Cleared Jul 09, 2026
Zeta TMS Navigation System
K261471 · QFF
Zeta Surgical, Inc.
Neurology · 66d
Cleared Jul 09, 2026
Millipede88 Access Catheter
K253901 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Jul 01, 2026
Trevo Trak 21 Microcatheter
K261889 · QJP
Stryker Neurovascular
Neurology · 26d
Cleared Jun 27, 2026
SOMNUM (SOMNUM)
K253390 · OLZ
Honeynaps Co., Ltd.
Neurology · 270d
Cleared Jun 27, 2026
BraiN20® (BraiN20)
K253301 · GWF
Time IS Brain, S.L.
Neurology · 271d
Cleared Jun 26, 2026
Charlotte ACC25 Surface Electrode Array
K261442 · GXY
Cadwell Industries, Inc.
Neurology · 57d
Cleared Jun 26, 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 137d
Cleared Jun 25, 2026
iD3 Nav Decompression Probe (NTX-9005)
K260992 · PDQ
Neuralytix
Neurology · 91d
Cleared Jun 25, 2026
ClearFit Ti Ring 14mm (171750)
K260709 · GXN
Longeviti Neuro Solutions
Neurology · 113d
Cleared Jun 24, 2026
Target Xtra Detachable Coil
K261772 · HCG
Stryker Neurovscular
Neurology · 26d
Cleared Jun 24, 2026
Ceribell Neurology Review Software
K260998 · OMB
Ceribell, Inc.
Neurology · 90d
Cleared Jun 23, 2026
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682)
K261004 · JXG
Integra Lifesciences Production...
Neurology · 89d
Cleared Jun 18, 2026
3D MAC Titanium Cranial Plate (TCP) System
K253116 · GXN
The Surgeon General, Department of...
Neurology · 267d
Cleared Jun 17, 2026
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
K253055 · GYD
Nordic Kinetics AB
Neurology · 268d