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
121–144 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
K252146 · NFO
Shenzhen Siken 3D Technology...
Neurology · 167d
Cleared Dec 23, 2025
VEINOPLUS Back
K251958 · NUH
Dynapulse Medical
Neurology · 181d
Cleared Dec 22, 2025
EmbraceMini
K252981 · LEL
Empatica S.R.L.
Neurology · 96d
Cleared Dec 14, 2025
Hypnos (369054-200)
K250851 · OLZ
Cadwell Industries, Inc.
Neurology · 268d
Cleared Dec 11, 2025
Target Detachable Coil
K252694 · HCG
Stryker Neurovascular
Neurology · 107d
Cleared Dec 10, 2025
Intellidrop
K251598 · JXG
Brainspace, Inc.
Neurology · 197d
Cleared Dec 08, 2025
Ceribell Delirium Monitor System
K251936 · NCG
Ceribell, Inc.
Neurology · 167d
Cleared Dec 03, 2025
Bendit17 Microcatheter
K252213 · QJP
Bend IT Technologies, Ltd.
Neurology · 141d
Cleared Dec 03, 2025
HippoMind (v1.0)
K251881 · OLT
Hippoclinic
Neurology · 168d
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · JXG
Sophysa
Neurology · 270d
Cleared Nov 26, 2025
0.014” Willow Guidewire
K253168 · MOF
Arbor Endovascular, LLC
Neurology · 61d
Cleared Nov 25, 2025
NX01 (NX01)
K251550 · OMC
Naox Technologies Sas
Neurology · 188d
Cleared Nov 24, 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · NUH
Bozhou Rongjian Medical Appliance...
Neurology · 90d
Cleared Nov 21, 2025
LEGACY
K252696 · HBG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 21, 2025
Ceribell Infant Seizure Detection Software
K252070 · OMB
Ceribell, Inc.
Neurology · 143d
Cleared Nov 21, 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 157d
Cleared Nov 21, 2025
Nelli (Version 7.11)
K251506 · POS
Neuro Event Labs OY
Neurology · 189d
Cleared Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
K251191 · GXQ
Collagen Matrix, Inc.
Neurology · 215d
Cleared Nov 17, 2025
DeepRESP
K252330 · OLZ
Nox Medical Ehf
Neurology · 115d
Cleared Nov 14, 2025
ARC-EX System
K251821 · SDO
Onward Medical, Inc.
Neurology · 154d
Not Cleared Nov 14, 2025
Neurolyser XR (NXR100)
DEN250015 · SGN
Fusmobile, Inc.
Neurology · 203d
Cleared Nov 12, 2025
Synthes Patient Specific Implants
K243715 · GXN
Synthes GmbH
Neurology · 345d
Cleared Nov 10, 2025
KLS Martin Cranial Implants - MR Conditional
K252573 · GXN
KLS-Martin L.P.
Neurology · 88d
Cleared Nov 10, 2025
NeVasc Aspiration System
K251006 · NRY
Vesalio, Inc.
Neurology · 223d