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
1321–1344 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Not Cleared Apr 24, 2019
Comaneci, Comaneci Petit, Comaneci 17
DEN170064 · PUU
Rapid Medical , Ltd.
Neurology · 573d
Not Cleared Apr 19, 2019
Monarch eTNS System
DEN180041 · QGL
Neurosigma, Inc.
Neurology · 263d
Cleared Apr 17, 2019
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion...
K183043 · NRY
Imperative Care, Inc.
Neurology · 166d
Cleared Apr 12, 2019
D-Clip
K180757 · HCH
Peter Lazic GmbH
Neurology · 386d
Cleared Apr 11, 2019
Codman Electrosurgical Generator, Foot Pedal
K183526 · GEI
Kls Martin GmbH + Co. KG
Neurology · 113d
Cleared Apr 10, 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662 · PDQ
Boston Endo Surgical Tech,
Neurology · 197d
Cleared Apr 04, 2019
Dome Electrode
K190416 · GXY
Coapt, LLC
Neurology · 42d
Cleared Apr 03, 2019
DAEHAN Disposable CUP Electrodes
K180232 · GXY
Daehan Medical Systems Co., Ltd.
Neurology · 429d
Cleared Apr 03, 2019
HORIZON TMS Therapy System with Navigation
K183376 · OBP
Magstim Company, Ltd.
Neurology · 118d
Cleared Mar 29, 2019
Freedom Spinal Cord Stimulator (SCS) System
K182720 · GZB
Stimwave Technologies Incorporated
Neurology · 182d
Cleared Mar 29, 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu...
K183579 · GZF
Boston Scientific Neuromodulation
Neurology · 98d
Not Cleared Mar 28, 2019
Leica FL400
DEN180024 · QFX
Leica Microsystems (Schweiz) AG
Neurology · 335d
Cleared Mar 26, 2019
SM Electrodes
K183154 · GXY
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 132d
Cleared Mar 22, 2019
Nexstim Navigated Brain Therapy (NBT) System 2
K182700 · OBP
Nexstim Plc
Neurology · 176d
Cleared Mar 22, 2019
Nalu Neurostimulation System
K183047 · GZB
Boston Scientific Neuromodulation
Neurology · 140d
Cleared Mar 22, 2019
Aristotle 18 Guidewire, 200cm, Soft Profile
K183608 · MOF
Scientia Vascular, LLC
Neurology · 86d
Cleared Mar 21, 2019
Ballast 088 Long Sheath
K182918 · DQY
Balt USA, LLC
Neurology · 153d
Cleared Mar 21, 2019
Route 92 Medical Delivery Catheter
K190431 · DQY
Route 92 Medical, Inc.
Neurology · 27d
Cleared Mar 19, 2019
AE-120A EEG Head Set
K183529 · OMC
Nihon Kohden Corporation
Neurology · 90d
Cleared Mar 15, 2019
HORIZON TMS Therapy System
K182853 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Mar 15, 2019
HIVOX OTC Electrical Stimulator
K190347 · NUH
Hivox Biotek, Inc.
Neurology · 29d
Cleared Mar 14, 2019
JKH Stimulator Plus
K182203 · NUH
Jkh USA, LLC
Neurology · 211d
Cleared Mar 14, 2019
L300 Go System
K190285 · GZI
Bioness, Inc.
Neurology · 31d
Cleared Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access...
K183463 · DQY
Stryker
Neurology · 89d