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
313–336 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 09, 2025
PATH BGC
K242392 · QJP
Crossroads Neurovascular, Inc.
Neurology · 270d
Cleared May 09, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
K250053 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 119d
Cleared May 06, 2025
ANKYRAS
K250160 · PZO
Mentice Spain S.L.
Neurology · 105d
Cleared May 01, 2025
APRO 45 Catheter
K251014 · DQY
Alembic, LLC
Neurology · 29d
Cleared Apr 30, 2025
APRO 45 Catheter and Alembic Aspiration Tubing
K251015 · NRY
Alembic, LLC
Neurology · 28d
Cleared Apr 29, 2025
APRO 55 Intermediate Catheter
K250962 · DQY
Alembic, LLC
Neurology · 29d
Cleared Apr 28, 2025
APRO 55 Swift Catheter and Alembic Aspiration Tubing
K250958 · NRY
Alembic, LLC
Neurology · 28d
Cleared Apr 25, 2025
Neu Platform
K250153 · GYD
Neuhealth Digital , Ltd.
Neurology · 94d
Cleared Apr 24, 2025
Freespira Breathing System
K233337 · SEN
Freespira, Inc.
Neurology · 573d
Cleared Apr 21, 2025
CHIKAI Nexus 014
K243383 · MOF
Asahi Intecc Co., Ltd.
Neurology · 172d
Cleared Apr 18, 2025
SofWave System
K250146 · NGX
Sofwave Medical, Ltd.
Neurology · 87d
Cleared Apr 17, 2025
Ultimate rTMS for OCD (M-series)
K243459 · QCI
Brain Ultimate, Inc.
Neurology · 160d
Cleared Apr 17, 2025
Ultimate rTMS
K243460 · OBP
Brain Ultimate, Inc.
Neurology · 160d
Not Cleared Apr 17, 2025
Minder System
DEN240062 · SEM
Epi-Minder Pty, Ltd.
Neurology · 181d
Cleared Apr 16, 2025
DCM (PW-DCM)
K243513 · LEL
Pneumowave, Ltd.
Neurology · 155d
Cleared Apr 14, 2025
Atlas Stim Headbox (NK) (31-0601-0077)
K250094 · GYC
Neuralynx, Inc.
Neurology · 90d
Cleared Apr 11, 2025
Canvas Dx
K243558 · QPF
Cognoa, Inc.
Neurology · 144d
Not Cleared Apr 11, 2025
CT-132
DEN240064 · SEE
Click Therapeutics, Inc.
Neurology · 150d
Cleared Apr 10, 2025
NEAT 001
K250058 · OLZ
Brain Electrophysiology Laboratory...
Neurology · 90d
Cleared Apr 10, 2025
cryoICE cryoXT cryoablation probe (cryoXT)
K250371 · GXH
AtriCure, Inc.
Neurology · 59d
Cleared Apr 09, 2025
Ceribell Seizure Detection Software
K241589 · OMB
Ceribell, Inc.
Neurology · 310d
Cleared Apr 09, 2025
Patch-TEA (Model TRI-21)
K243613 · NUH
Transtimulation Research, Inc.
Neurology · 138d
Cleared Apr 09, 2025
autoSCORE (V 2.0.0)
K243743 · OMB
Holberg Eeg AS
Neurology · 126d
Cleared Apr 09, 2025
AURORA® Surgiscope® System (ASX15/60)
K250752 · GWG
Integra LifeSciences Corporation
Neurology · 28d