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
985–1008 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 25, 2021
Nalu Neurostimulation System
K203547 · GZB
Boston Scientific Neuromodulation
Neurology · 111d
Cleared Mar 23, 2021
TrueRelief Device
K202186 · GZJ
Truerelief
Neurology · 231d
Cleared Mar 23, 2021
Tigertriever and Tigertriever 17 Revascularization Devce
K203592 · NRY
Rapid Medical , Ltd.
Neurology · 105d
Cleared Mar 18, 2021
Clarus Peel-Away Introducer Sheath
K200925 · GWG
Clarus Medical, LLC
Neurology · 345d
Cleared Mar 17, 2021
Neurosign V4 Intraoperative Nerve Monitor
K203684 · PDQ
Magstim Company, Ltd.
Neurology · 90d
Cleared Mar 10, 2021
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2
K203574 · NUH
Hivox Biotek, Inc.
Neurology · 93d
Cleared Mar 08, 2021
iCE-SG Subcutaneous Electrode Arrays
K201678 · GZL
Ice Neurosystems, Inc.
Neurology · 262d
Cleared Mar 05, 2021
NeuroCap (Model DEC22)
K202913 · GXY
Memory MD, Inc.
Neurology · 157d
Cleared Mar 03, 2021
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T...
K203764 · QJP
Imperative Care, Inc.
Neurology · 70d
Cleared Mar 01, 2021
Solitaire X Revascularization Device
K203358 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 105d
Cleared Feb 25, 2021
Phenom Catheters
K210230 · DQY
Micro Therapeutics Lnc. D/B/A Ev3...
Neurology · 28d
Cleared Feb 24, 2021
Trinity ELE Plus and Trinity ELE Plus Pro
K201906 · NFO
Carol Cole Company Dba Nuface
Neurology · 230d
Cleared Feb 24, 2021
BioWaveGO RX
K210202 · GZJ
Biowave Corporation
Neurology · 30d
Cleared Feb 19, 2021
NuFACE Mini Plus
K201680 · NFO
Carole Cole Company
Neurology · 242d
Cleared Feb 16, 2021
Relivion
K203419 · PCC
Neurolief , Ltd.
Neurology · 89d
Cleared Feb 16, 2021
Rebar Micro Catheter
K210114 · KRA
Micro Therapeuatics, Inc. D/B/A Ev3...
Neurology · 28d
Cleared Feb 12, 2021
gammaCore Sapphire
K203546 · PKR
Electrocore, Inc.
Neurology · 70d
Cleared Feb 10, 2021
DSG Connect Technology
K201454 · PDQ
Spineguard S.A.
Neurology · 254d
Cleared Feb 10, 2021
Digital NeuroPort Biopotential Signal Processing System
K202174 · GWL
Blackrock Microsystems
Neurology · 190d
Cleared Feb 09, 2021
Stryker PEEK Customized Cranial Implant Kit
K203055 · GWO
Stryker
Neurology · 124d
Cleared Feb 09, 2021
MR Conditional Sticky Pad Electrode
K203079 · GXY
Rhythmlink International, LLC
Neurology · 119d
Cleared Feb 06, 2021
SPEAC System
K200276 · POS
Brain Sentinel, Inc.
Neurology · 368d
Cleared Feb 03, 2021
Jiajian Self-Adhesive Electrode
K192568 · GXY
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 504d
Cleared Feb 03, 2021
AXUS ES-5 Electro-Acupuncture Device
K200636 · BWK
Lhasa Oms, Inc.
Neurology · 330d