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
1033–1056 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 CT 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 CT 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 CT 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
Cleared Jan 29, 2021
Disposable Pre-calibrated Suction
K201752 · HAW
Brainlab AG
Neurology · 217d
Cleared Jan 29, 2021
MAGIC Infusion Catheter
K202366 · KRA
Balt USA, LLC
Neurology · 163d
Cleared Jan 28, 2021
BOSS 8F Balloon Guide Catheter
K203840 · QJP
Marblehead Medical, LLC
Neurology · 28d
Cleared Jan 22, 2021
NuFace Trinity Plus Device
K201782 · NFO
Carol Cole Company Dba Nuface
Neurology · 206d
Cleared Jan 22, 2021
ClearPoint Array System
K202575 · HAW
ClearPoint Neuro, Inc.
Neurology · 140d