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
169–192 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 29, 2025
allay Nerve Cap (TL5515-1)
K252051 · SBG
Tulavi Therapeutics, Inc.
Neurology · 90d
Cleared Sep 26, 2025
Optima Coil System (Optima Packing Coil System)
K252700 · HCG
Balt USA, LLC
Neurology · 30d
Cleared Sep 25, 2025
EMBOTRAP III Revascularization Device
K251789 · NRY
Neuravi Limited
Neurology · 106d
Cleared Sep 19, 2025
UniBur
K252662 · HBE
Nakanishi, Inc.
Neurology · 28d
Cleared Sep 18, 2025
Sunny Plus (Sunny)
K251649 · NFO
ShenB Co., Ltd.
Neurology · 112d
Cleared Sep 14, 2025
CloudTMS Edge
K250689 · OBP
Teleemg, LLC
Neurology · 192d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Brainsway , Ltd.
Neurology · 127d
Cleared Sep 12, 2025
Legend X Platform
K252576 · GEI
Pollogen, Ltd.
Neurology · 29d
Cleared Sep 08, 2025
Coaptium Connect with Tissium Light
K251957 · SFD
Tissium SA
Neurology · 75d
Cleared Sep 08, 2025
DUO Microcatheter
K250960 · QJP
Rev Neuro, LLC
Neurology · 161d
Cleared Sep 05, 2025
SOLOPASS 2.0 System
K251317 · HAW
Intravent Medical Partners
Neurology · 129d
Cleared Sep 04, 2025
Mobile Laser Unit (1001-N2)
K251298 · ONO
Clinical Laserthermia Systems, AB
Neurology · 129d
Cleared Sep 04, 2025
Ball Joint Guide Array (66295)
K250893 · HAW
Bayer Medical Care, Inc.
Neurology · 163d
Cleared Sep 04, 2025
Apollo TMS Therapy System
K243700 · OBP
Mag & More GmbH
Neurology · 279d
Cleared Sep 03, 2025
NeurotriS (SX2500)
K251909 · NFO
A-1 Engineering
Neurology · 75d
Cleared Sep 03, 2025
SignalNED System (Model RE)
K251726 · OMC
Forest Devices, Inc.
Neurology · 90d
Cleared Aug 29, 2025
Millipede70 Aspiration Catheter
K252392 · NRY
Perfuze, Ltd.
Neurology · 29d
Cleared Aug 29, 2025
NEUROVENT-P (092946-003)
K250285 · GWM
Raumedic AG
Neurology · 210d
Cleared Aug 28, 2025
Somfit D
K252383 · MNR
Compumedics Limited
Neurology · 28d
Cleared Aug 26, 2025
X-Wire Guidewire
K244061 · MOF
Imperative Care, Inc.
Neurology · 238d
Cleared Aug 25, 2025
Sparrow Ascent
K251246 · PZR
Spark Biomedical, Inc.
Neurology · 125d
Cleared Aug 22, 2025
CEREGLIDE 71 Catheter System
K251828 · NRY
Cerenovus, Inc.
Neurology · 70d
Cleared Aug 21, 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/...
K250784 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 160d
Not Cleared Aug 20, 2025
Delphi-MD System
DEN250002 · SFN
Quantalx Neuroscience, Ltd.
Neurology · 229d