FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
1825–1848 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 30, 2015
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY...
K150046 · NCX
Zoll Circulation, Inc.
Neurology · 291d
Cleared Oct 30, 2015
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8...
K152040 · OMC
Advanced Brain Monitoring, Inc.
Neurology · 100d
Cleared Oct 30, 2015
DURAFORM Dural Graft Implant
K152481 · GXQ
Codman & Shurtleff, Inc.
Neurology · 60d
Cleared Oct 27, 2015
Codman Certas Plus Programmable Valve
K152152 · JXG
Medos International SARL
Neurology · 85d
Cleared Oct 23, 2015
ICS CHARTR EP 200 WITH VEMP
K143670 · GWJ
Gn Otometrics A/S
Neurology · 303d
Cleared Oct 23, 2015
R-40 EEG Amplifier
K151600 · GWL
Lifelines , Ltd.
Neurology · 133d
Cleared Oct 21, 2015
ClearPoint System
K142505 · HAW
Mri Interventions, Inc.
Neurology · 411d
Cleared Oct 20, 2015
Palm TENS
K150308 · NUH
Heat IN A Click, LLC
Neurology · 253d
Cleared Oct 19, 2015
QBioScan
K150804 · GZO
Medeia, Inc.
Neurology · 207d
Cleared Oct 16, 2015
EV-820 OTC Pain Relief TENS
K151479 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 136d
Cleared Oct 09, 2015
Dr-Ho's Foot Pad Electrode
K151693 · GXY
Drtv Asia, Ltd.
Neurology · 108d
Cleared Sep 29, 2015
Neon EEG
K151576 · GXY
Incereb, Ltd.
Neurology · 110d
Cleared Sep 25, 2015
BiowaveHOME Neuromodulation Pain Therapy Device
K152437 · GZJ
Biowave Corporation
Neurology · 29d
Cleared Sep 24, 2015
SudoC
K152216 · GZO
Ld Technology, LLC
Neurology · 48d
Cleared Sep 18, 2015
STARband, STARlight
K151979 · OAN
Orthomerica Products, Inc.
Neurology · 63d
Cleared Sep 09, 2015
NFANT Feeding Solution
K143507 · HCC
Nfant Labs, LLC
Neurology · 273d
Cleared Sep 02, 2015
DirectInject
K143661 · GXP
Stryker
Neurology · 253d
Cleared Aug 28, 2015
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN...
K143433 · IKT
Natus Manufacturing Limited
Neurology · 270d
Cleared Aug 28, 2015
ANAM Test System: Military Battery
K150154 · PKQ
Vista Lifesciences, Inc.
Neurology · 217d
Cleared Aug 27, 2015
RxG Distraction System
K150771 · PBJ
KLS-Martin L.P.
Neurology · 156d
Cleared Aug 26, 2015
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
K152076 · GWO
Stryker
Neurology · 30d
Cleared Aug 25, 2015
Zekang Self-adhesive Electrode
K150971 · GXY
Jiangsu Zekang Medical Technology...
Neurology · 134d
Cleared Aug 21, 2015
Lifelines iEEG
K143487 · OLT
Kvikna Ehf
Neurology · 256d
Cleared Aug 19, 2015
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
K150220 · GWF
Eb Neuro S.P.A.
Neurology · 201d