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
1273–1296 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 01, 2019
Synchro2 Support Guidewire
K190843 · MOF
Stryker
Neurology · 30d
Cleared Apr 30, 2019
Eclipse 2L
K183045 · MJN
Balt USA, LLC
Neurology · 179d
Cleared Apr 26, 2019
Portable Electro-Stimulation Therapy Device
K182108 · NUH
Guangzhou Longest Science &...
Neurology · 266d
Cleared Apr 26, 2019
Penumbra System 3D Revascularization Device
K190464 · NRY
Penumbra, Inc.
Neurology · 59d
Cleared Apr 24, 2019
AXS Vecta Aspiration System
K190212 · NRY
Stryker Neurovascular
Neurology · 79d
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