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
409–432 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
K241389 · OPT
Infrascan, Inc.
Neurology · 211d
Cleared Dec 12, 2024
NExT Station
K242832 · GWL
Eb Neuro S.P.A.
Neurology · 84d
Cleared Dec 12, 2024
Natus Ultrapro S100 (982A0594)
K243495 · GWF
Natus Neurology Incorporated
Neurology · 30d
Cleared Dec 11, 2024
Disposable Subdermal Needle Electrode, Corkscrew
K241045 · GXZ
Technomed Europe
Neurology · 238d
Cleared Dec 11, 2024
Access25™ Delivery Microcatheter
K242033 · QJP
Penumbra, Inc.
Neurology · 153d
Cleared Dec 08, 2024
HomeSleepTest (HST, HST REM+)
K240700 · OLV
Somnomedics GmbH
Neurology · 269d
Cleared Dec 06, 2024
87 NeuGlide Catheter
K240971 · QJP
Piraeus Medical
Neurology · 241d
Cleared Dec 04, 2024
Socrates 38 Catheter
K242301 · QJP
Scientia Vascular, Inc.
Neurology · 124d
Cleared Nov 26, 2024
NeuroMatch
K241390 · OMB
LVIS Corporation
Neurology · 195d
Cleared Nov 25, 2024
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
K240575 · GXY
Eemagine Medical Imaging Solutions GmbH
Neurology · 269d
Cleared Nov 22, 2024
Neuvotion NeuStim NN-01
K240632 · GZI
Neuvotion, Inc.
Neurology · 261d
Cleared Nov 22, 2024
Dreem 3S
K242094 · OLZ
Beacon Biosignals, Inc.
Neurology · 128d
Cleared Nov 22, 2024
Cala kIQ
K242259 · QBC
Cala Health, Inc.
Neurology · 114d
Cleared Nov 22, 2024
Nooro Body & Foot Stimulator (SM9141, SM9142)
K243334 · NUH
Xf Agencija Limited
Neurology · 29d
Cleared Nov 20, 2024
Neurovascular Access System Family
K240746 · QJP
Q'Apel Medical, Inc.
Neurology · 246d
Cleared Nov 19, 2024
Natus BrainWatch System
K242930 · OMC
Natus Medical Incorporated Dba...
Neurology · 56d
Cleared Nov 18, 2024
Synxess Neurovascular Guidewire
K240871 · MOF
Enlight Medical Technologies...
Neurology · 234d
Not Cleared Nov 13, 2024
SmartFlow Neuro Cannula
DEN240023 · SDG
ClearPoint Neuro, Inc.
Neurology · 175d
Cleared Nov 12, 2024
pNOVUS 21 Microcatheter
K242420 · DQO
Phenox, Ltd.
Neurology · 89d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719 · PCC
Nu Eyne Co., Ltd.
Neurology · 57d
Cleared Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341,...
K242332 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 90d
Cleared Nov 05, 2024
Delphi Stimulator
K242345 · GWF
Quantalx Neuroscience
Neurology · 90d
Cleared Oct 29, 2024
Riptide Aspiration System
K243080 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157 · GXH
AtriCure, Inc.
Neurology · 29d