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
1201–1224 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 25, 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative...
K191186 · GYC
Ad-Tech Medical Instrument Corporation
Neurology · 267d
Cleared Jan 24, 2020
LCCS VC-S RF Cannula
K191293 · GXI
Lccs Products Limited
Neurology · 255d
Cleared Jan 24, 2020
cortiQ PRO
K191432 · OLU
G.Tec Medical Engineering GmbH
Neurology · 240d
Cleared Jan 22, 2020
E-EEGX, N-EEGX
K191322 · OLT
GE Healthcare Finland Oy
Neurology · 252d
Cleared Jan 21, 2020
Disposable Gold Cup EEG Electrodes
K192564 · GXY
Dymedix Diagnostics, Inc.
Neurology · 125d
Cleared Jan 18, 2020
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
K193548 · DQX
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Jan 17, 2020
SAC2 - Electrode Cream
K192606 · GYB
Spes Medica Srl
Neurology · 119d
Cleared Jan 17, 2020
CustomizedBone Service
K193547 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 28d
Cleared Jan 13, 2020
Route 92 Medical Sheath System
K191717 · DQY
Route 92 Medical, Inc.
Neurology · 201d
Cleared Jan 09, 2020
Longeviti ClearFit Cranial Implant
K191210 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 248d
Cleared Jan 03, 2020
NeuroBlate System
K193375 · GEX
Monteris Medical,
Neurology · 29d
Cleared Jan 02, 2020
Sterile LeadConfirm
K191739 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 188d
Cleared Dec 24, 2019
VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter...
K192135 · DQY
MicroVention, Inc.
Neurology · 139d
Cleared Dec 23, 2019
RIST Cath Radial Access Long Sheath
K191551 · DQY
Rist Neurovascular, Inc.
Neurology · 194d
Cleared Dec 21, 2019
Spinalytics
K192629 · LXM
Optima Health Solutions International...
Neurology · 89d
Cleared Dec 19, 2019
Everyway OTC TENS/EMS Combination
K192589 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Dec 17, 2019
CNS Envision
K192572 · OLT
Moberg Research, Inc.
Neurology · 90d
Cleared Dec 15, 2019
AXS Vecta Aspiration Catheter
K190833 · DQY
Stryker Neurovascular
Neurology · 258d
Cleared Dec 12, 2019
Health Expert Electronic Stimulator
K190673 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 272d
Cleared Dec 09, 2019
EyeStat
K191700 · GZP
Blinktbi, Inc.
Neurology · 167d
Cleared Dec 06, 2019
Aurora Surgiscope System
K191861 · GWG
Rebound Therapeutics
Neurology · 148d
Cleared Dec 06, 2019
ALLIVE
K192773 · PCC
Nu Eyne Co., Ltd.
Neurology · 67d
Cleared Dec 02, 2019
Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
K190009 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 333d
Cleared Nov 29, 2019
AXS Infinity LS Plus Long Sheath
K193034 · DQY
Stryker Neurovascular
Neurology · 29d