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
1–24 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared Aug 25, 2026
Report Studio
K261747 · OLV
Beacon Biosignals, Inc.
Neurology · 90d
Cleared Aug 23, 2026
BTL-699
K260691 · OBP
BTL Industries, Inc.
Neurology · 173d
Cleared Aug 20, 2026
Kneu Platform (V2)
K262515 · GYD
Kneu Health Digital , Ltd.
Neurology · 30d
Cleared Aug 19, 2026
Pascall Sensor Unit (PSU1)
K254213 · OLT
Pascall Systems, Inc.
Neurology · 233d
Cleared Aug 18, 2026
p17 XR Microcatheter
K254071 · QJP
Wallaby Medical
Neurology · 243d
Cleared Aug 16, 2026
CN-Suite™
K260563 · OLX
FIND Surgical Sciences Inc. D/B/A...
Neurology · 178d
Cleared Aug 14, 2026
Willow 12 Guidewire
K262424 · MOF
Arbor Endovascular, LLC
Neurology · 29d
Cleared Aug 14, 2026
MICRUSFRAME (MFR100202)
K262419 · HCG
Cerenovus, Inc.
Neurology · 30d
Cleared Aug 14, 2026
QuickVision Ultimate rTMS
K261228 · OBP
Brain Ultimate, Inc.
Neurology · 121d
Cleared Aug 14, 2026
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring
K260374 · GYD
Empatica S.R.L.
Neurology · 190d
Cleared Aug 13, 2026
CEREGLIDE 57 Intermediate Catheter
K262398 · NRY
Cerenovus, Inc.
Neurology · 30d
Cleared Aug 12, 2026
Millipede System
K262399 · NRY
Perfuze, Ltd.
Neurology · 29d
Cleared Aug 12, 2026
APRO 35 Swift Catheter
K262392 · DQY
Alembic, LLC
Neurology · 29d
Cleared Aug 12, 2026
APRO 35 Swift Catheter and Alembic Aspiration Tubing
K262391 · NRY
Alembic, LLC
Neurology · 29d
Cleared Aug 06, 2026
Aristotle Mini Guidewire
K260223 · MOF
Scientia Vascular, Inc.
Neurology · 192d
Cleared Aug 05, 2026
Leksell® Vantage Stereotactic System
K261932 · HAW
Elekta Solutions AB
Neurology · 57d
Cleared Aug 03, 2026
Eve
K260381 · PHL
Wandercraft SAS
Neurology · 179d
Cleared Jul 30, 2026
Motivista (CT-155)
K254038 · SAP
Click Therapeutics, Inc.
Neurology · 226d
Cleared Jul 30, 2026
TnR Cranial Implant
K251959 · GXP
T&R BIOFAB CO., Ltd.
Neurology · 399d