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
985–1008 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jul 27, 2021
Rist 071 Radial Access Guide Catheter
K211990 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jul 16, 2021
ExoAtlet-II
K201473 · PHL
Exoatlet Asia Co. , Ltd.
Neurology · 408d
Cleared Jul 08, 2021
BioWave BioWraps
K203158 · GXY
Biowave Corporation
Neurology · 259d
Cleared Jul 07, 2021
Axium Detachable Coil
K203432 · HCG
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 226d
Cleared Jul 02, 2021
RICOH MEG
K210199 · OLX
Ricoh Company, Ltd.
Neurology · 158d
Cleared Jul 01, 2021
Penumbra System (RED 68 Reperfusion Catheter)
K211411 · NRY
Penumbra, Inc.
Neurology · 56d
Cleared Jun 30, 2021
Stryker iBur hubs and cutting accessories
K210377 · HBE
Stryker Corporation
Neurology · 141d
Cleared Jun 18, 2021
Transcutaneous Electrical Nerve Stimulator
K202893 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 263d
Cleared Jun 17, 2021
Migraine Tens Digital Pain Reliever
K210364 · PCC
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 129d
Cleared Jun 17, 2021
NaviNetics D1 Stereotactic System
K210700 · HAW
Navinetics, Inc.
Neurology · 100d
Cleared Jun 16, 2021
EnsoSleep
K210034 · OLZ
Ensodata, Inc.
Neurology · 161d
Cleared Jun 11, 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K210756 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 88d
Cleared Jun 08, 2021
ZOOM 71 Reperfusion Catheter
K211476 · NRY
Imperative Care, Inc.
Neurology · 27d
Cleared Jun 07, 2021
SnugKap
K193383 · MVA
Headstart, Ltd.
Neurology · 550d
Cleared Jun 04, 2021
Perfect EMS
K200694 · NUH
Tenscare, Ltd.
Neurology · 444d
Cleared Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309 · JXL
Mecta Corporation
Neurology · 385d
Not Cleared Jun 02, 2021
Cognoa ASD Diagnosis Aid
DEN200069 · QPF
Cognoa, Inc.
Neurology · 211d
Cleared Jun 01, 2021
Well-Life Garment Electrodes (GM Series)
K200942 · GXY
Well-Life Healthcare Limited
Neurology · 419d
Cleared May 28, 2021
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3...
K211344 · HCG
Medos International SARL
Neurology · 25d
Cleared May 22, 2021
Neuro-IOM system with Neuro-IOM.NET software
K190703 · GWF
Neurosoft , Ltd.
Neurology · 796d
Cleared May 20, 2021
Quick-20m
K203331 · GWL
Cgx, LLC
Neurology · 189d
Cleared May 20, 2021
Penumbra System (Reperfusion Catheter RED 62)
K203440 · NRY
Penumbra, Inc.
Neurology · 178d
Cleared May 04, 2021
Rebellion, Phantom Multi-Bite Kerrison Rongeur 
K200768 · HAE
Morpheus AG
Neurology · 405d
Cleared Apr 30, 2021
CereLink ICP Monitor
K210993 · GWM
Integra Lifesciences Production...
Neurology · 28d