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
145–168 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 19, 2026
Willow 24 Guidewire
K260537 · MOF
Arbor Endovascular, LLC
Neurology · 30d
Cleared CT Mar 17, 2026
Cala kIQ Plus
K253587 · QBC
Cala Health, Inc.
Neurology · 120d
Cleared CT 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 CT 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
Cleared Feb 13, 2026
PreOp v3
K252565 · OLX
Clouds of Care
Neurology · 183d
Cleared Feb 13, 2026
STAR RF Ablation System
K251802 · GXI
Merit Medical Systems, Inc.
Neurology · 246d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 09, 2026
Ceribell Instant EEG Headset
K254033 · GXY
Ceribell, Inc.
Neurology · 55d
Cleared Feb 05, 2026
Encora X1
K251517 · QBC
Encora, Inc.
Neurology · 265d
Cleared Feb 02, 2026
CHIKAI Nexus petit
K252011 · MOF
Asahi Intecc Co., Ltd.
Neurology · 220d
Cleared Jan 27, 2026
Optima Coil System (OptiOne Coil System)
K254221 · HCG
Balt USA, LLC
Neurology · 29d