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
1225–1248 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 16, 2019
GIM-STIM OTC TENS/EMS System
K190988 · NUH
Gemore Technology Co, Ltd.
Neurology · 123d
Cleared Aug 09, 2019
ELAN 4 Tools
K183203 · HBE
Aesculap, Inc.
Neurology · 263d
Cleared Aug 05, 2019
EEG Electrode Template
K191225 · GXY
Rhythmlink International, LLC
Neurology · 90d
Cleared Aug 02, 2019
046 Zenith Flex
K190338 · NRY
Inneuroco, Inc.
Neurology · 169d
Cleared Aug 01, 2019
Mini TENS Therapy Device
K182871 · NUH
Shenzhen Jumper Medical Equipment...
Neurology · 293d
Cleared Aug 01, 2019
Leksell Vantage Stereotactic System
K190887 · HAW
Elekta Instrument AB
Neurology · 119d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Medtronic Navigation, Inc.
Neurology · 138d
Cleared Jul 31, 2019
EyeBOX
K191183 · QEA
Oculogica, Inc.
Neurology · 90d
Cleared Jul 30, 2019
Transcutaneous Electrical Nerve Stimulator
K183288 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 246d
Cleared Jul 30, 2019
AXS Vecta Aspiration System
K191768 · NRY
Stryker Neurovascular
Neurology · 29d
Cleared Jul 26, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K182889 · PPT
KLS-Martin L.P.
Neurology · 284d
Cleared Jul 26, 2019
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
K191714 · MOF
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jul 20, 2019
CerusEndo Microcatheter
K182487 · DQY
Cerus Endovascular, Inc.
Neurology · 312d
Cleared Jul 19, 2019
Anspach Helix Dissection Tools
K183545 · HBE
The Anspach Effort, Inc.
Neurology · 211d
Cleared Jul 19, 2019
Tech Dots - Adhesive and conductive gel
K190050 · GYB
Spes Medica Srl
Neurology · 190d
Cleared Jul 16, 2019
ALARA Neuro Access Kit
K190163 · PDQ
SurGenTec, LLC
Neurology · 166d
Cleared Jul 15, 2019
087 Balloon Guide Catheter System
K190749 · DQY
Q'Apel
Neurology · 112d
Cleared Jul 14, 2019
Modus Nav
K183325 · HAW
Synaptive Medical, Inc.
Neurology · 226d
Cleared Jul 11, 2019
Stryker PEEK Customized Cranial Implant Kit
K190229 · GWO
Stryker
Neurology · 156d
Cleared Jul 11, 2019
Nalu Lead Blank (50cm)
K190960 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Jul 10, 2019
Scepter Mini Occlusion Balloon Catheter
K182829 · DQY
MicroVention, Inc.
Neurology · 278d
Cleared Jul 10, 2019
PressOn Electrode Headset
K190801 · GXZ
Rhythmlink International, LLC
Neurology · 103d
Cleared Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · JXG
Aesculap, Inc.
Neurology · 154d
Cleared Jul 02, 2019
Wrap accessory electrodes
K190617 · GXY
Hi-Dow International, Inc.
Neurology · 113d