FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
73–96 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 03, 2026
Ceribell Brain Monitor Headband
K260363 · GXY
Ceribell, Inc.
Neurology · 58d
Not Cleared Apr 03, 2026
neuropacs
DEN240071 · SHO
Automated Imaging Diagnostics, LLC
Neurology · 485d
Cleared Mar 26, 2026
Surgify Halo (54.085.SHD.U1)
K253627 · HBE
Surgify Medical OY
Neurology · 127d
Cleared Mar 26, 2026
Stealth AXiS Cranial clinical application
K253379 · HAW
Medtronic Navigation, Inc.
Neurology · 177d
Cleared Mar 20, 2026
Noxturnal Web
K260585 · OLV
Nox Medical Ehf
Neurology · 28d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · OBP
Nexstim Oyj
Neurology · 178d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · OBP
Nexstim Oyj
Neurology · 234d
Cleared Mar 19, 2026
Willow 24 Guidewire
K260537 · MOF
Arbor Endovascular, LLC
Neurology · 30d
Cleared Mar 17, 2026
Cala kIQ Plus
K253587 · QBC
Cala Health, Inc.
Neurology · 120d
Cleared Mar 16, 2026
Millipede System
K253590 · NRY
Perfuze, Ltd.
Neurology · 119d
Cleared Mar 16, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447 · GXR
Orthocon, Inc.
Neurology · 165d
Cleared Mar 16, 2026
DCwire Micro-guidewire
K252122 · MOF
Shanghai Achieva Medical Suzhou Co.,...
Neurology · 252d
Cleared Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
K253581 · IKT
Technomed Europe
Neurology · 118d
Cleared Mar 13, 2026
New Wave System
K260455 · GWQ
Zeto, Inc.
Neurology · 30d
Cleared Mar 13, 2026
Permatage Flowable, Settable Bone Paste
K253732 · GXP
Orthocon, Inc.
Neurology · 109d
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · ONO
Medtronic Navigation, Inc.
Neurology · 164d
Cleared Mar 13, 2026
IASIS i2 Relaxation Neurofeedback System
K252923
Iasis Technologies
Neurology · 179d
Cleared Mar 12, 2026
Tigertriever 25 Revascularization Device
K253062 · NRY
Rapid Medical , Ltd.
Neurology · 171d
Cleared Mar 08, 2026
Onera SleepMap (SLEEPMAP)
K253668 · OLZ
Onera B.V.
Neurology · 107d
Cleared Mar 06, 2026
Velocity Alpha MR High Speed Surgical Drill System
K253772 · HBB
Adeor Medical AG
Neurology · 100d
Cleared Mar 05, 2026
EarliPoint Assessment
K253442 · QPF
Earlitec Diagnostics
Neurology · 155d
Cleared Mar 04, 2026
TENS/EMS device (GUSE01)
K253896 · NUH
Globalcare Medical Technology Co., Ltd.
Neurology · 89d
Cleared Feb 20, 2026
SPRY TMS Therapy System (0550)
K251653 · OBP
Soterix Medical, Inc.
Neurology · 267d
Cleared Feb 13, 2026
Willow 18 Guidewire
K260130 · MOF
Arbor Endovascular, LLC
Neurology · 28d