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
913–936 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 10, 2021
gammaCore Sapphire
K211856 · PKR
Electrocore, Inc.
Neurology · 86d
Cleared Sep 08, 2021
Longeviti ClearFit™ OTS Cranial Implants
K212058 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 69d
Cleared Sep 05, 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T,...
K211736 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 90d
Cleared Sep 01, 2021
Numen Coil Embolization System
K203625 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 264d
Cleared Sep 01, 2021
Evo sEEG System
K211367 · GZL
Neuroone Medical Technologies Corp.
Neurology · 120d
Cleared Sep 01, 2021
Bonine Acupressure Bands
K211823 · MVV
Wellspring Pharmaceutical Corporation
Neurology · 79d
Cleared Aug 31, 2021
Adhesive Electrode
K210448 · GXY
Shaoxing Yingtuo Healthcare Co., Ltd.
Neurology · 196d
Cleared Aug 30, 2021
Ceribell Instant EEG Headband
K210805 · GXY
Ceribell, Inc.
Neurology · 166d
Cleared Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
K202752 · QJP
Stryker Neurovascular
Neurology · 340d
Cleared Aug 27, 2021
Neuspera Neurostimulation System (NNS)
K202781 · GZF
Neuspera Medical, Inc.
Neurology · 339d
Cleared Aug 27, 2021
Needle Stimulator
K202861 · BWK
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 333d
Cleared Aug 27, 2021
SOLOPASS System
K203251 · HAW
Intravent Medical Partners, LP
Neurology · 296d
Cleared Aug 27, 2021
Trevo NXT ProVue Retriever
K210502 · POL
Stryker Neurovascular
Neurology · 186d
Cleared Aug 25, 2021
Balloon Guiding Catheter
K202916 · QJP
Shanghai Heartcare Medical Technology...
Neurology · 330d
Cleared Aug 25, 2021
PROWLER SELECT PLUS
K210838 · KRA
Medos International SARL
Neurology · 156d
Cleared Aug 24, 2021
ELAN 4 Electro Motor System
K203739 · HBE
Aesculap, Inc.
Neurology · 245d
Not Cleared Aug 23, 2021
SureTune4 Software
DEN210003 · QQC
Medtronic Neuromodulation
Neurology · 201d
Cleared Aug 17, 2021
Deep Transcranial Magnetic Stimulation (DTMS) System
K210201 · OBP
Brainsway , Ltd.
Neurology · 204d
Cleared Aug 17, 2021
STARband
K211376 · OAN
Orthomerica Products, Inc.
Neurology · 105d
Cleared Aug 16, 2021
Metallic Fabric Electrodes
K202636 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 339d
Cleared Aug 16, 2021
Penumbra System (Reperfusion Catheter RED 72)
K211654 · NRY
Penumbra, Inc.
Neurology · 80d
Cleared Aug 13, 2021
MEGA-TMS
K192823 · GWF
Soterix Medical, Inc.
Neurology · 681d
Cleared Aug 06, 2021
1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable,...
K211202 · GWG
Stryker
Neurology · 106d
Cleared Aug 05, 2021
SelectFlex Neurovascular Access System Family
K211893 · QJP
Q'Apel Medical, Inc.
Neurology · 45d