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
1225–1248 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Nov 27, 2019
Optimus NEURO System - Sterile Kit
K190811 · GWO
Osteonic Co., Ltd.
Neurology · 243d
Cleared Nov 27, 2019
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
K192945 · HAW
7D Surgical, Inc.
Neurology · 40d
Cleared Nov 26, 2019
NeuroOne Cortical Electrode
K192764 · GYC
Neuroone, Inc.
Neurology · 57d
Cleared Nov 23, 2019
Cadwell Bolt Software
K190760 · OLT
Cadwell Industries, Inc.
Neurology · 243d
Cleared Nov 22, 2019
Healy
K191075 · NUH
Timewaver Production GmbH
Neurology · 213d
Cleared Nov 22, 2019
Trevo Trak 21 Microcatheter
K192122 · DQO
Stryker
Neurology · 108d
Cleared Nov 22, 2019
Trevo NXT ProVue Retriever
K192207 · POL
Stryker
Neurology · 100d
Cleared Nov 22, 2019
Spes Medica Subdermal Needle Electrodes
K192603 · GXZ
Spes Medica Srl
Neurology · 63d
Cleared Nov 21, 2019
M. Blue Adjustable Shunt System
K192266 · JXG
Aesculap, Inc.
Neurology · 92d
Cleared Nov 20, 2019
Penumbra LP Coil System
K192955 · HCG
Penumbra, Inc.
Neurology · 30d
Cleared Nov 15, 2019
Arcus Head Fixation Frame
K191701 · HBL
Mri Interventions, Inc.
Neurology · 143d
Cleared Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289 · JXG
Irras USA, Ltd.
Neurology · 84d
Cleared Nov 13, 2019
Nox Sleep System
K192469 · OLZ
Nox Medical
Neurology · 65d
Cleared Nov 08, 2019
CERENOVUS Large Bore Catheter
K191237 · DQY
Codman & Shurtleff, Inc.
Neurology · 184d
Cleared Nov 07, 2019
SandShark Injectable Anchor (SIA) System
K191466 · GZB
Stimwave Technologies, Inc.
Neurology · 157d
Cleared Nov 01, 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · HAW
Medtronic Navigation, Inc.
Neurology · 137d
Cleared Nov 01, 2019
Combo Electrotherapy Device
K192087 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 88d
Cleared Oct 31, 2019
StimRouter Neuromodulation System
K190047 · GZF
Bioness, Inc.
Neurology · 295d
Cleared Oct 31, 2019
087 Balloon Guide Catheter System
K192525 · DQY
Q'Apel Medical, LLC
Neurology · 48d
Cleared Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783 · DQX
Scientia Vascular, LLC
Neurology · 30d
Cleared Oct 22, 2019
DORO QR3 XTom Headholder System
K191979 · HBL
Pro-Med Instruments GmbH
Neurology · 90d
Cleared Oct 18, 2019
ATEC IOM Accessory Instruments
K191723 · PDQ
Alphatec Spine, Inc.
Neurology · 113d
Cleared Oct 17, 2019
BcSs-PICNI-2000 Sensor
K182073 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 442d
Cleared Oct 15, 2019
NuFACE Mini Device
K191672 · NFO
Carol Cole Company Dba Nuface
Neurology · 113d