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
1609–1632 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 26, 2017
VisualEyes
K163149 · GWN
Interacoustics A/S
Neurology · 168d
Cleared Apr 25, 2017
MyoCycle Home, MyoCycle Pro
K170132 · GZI
Myolyn, LLC
Neurology · 98d
Cleared Apr 21, 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · HAW
Medtronic Navigation, Inc.
Neurology · 210d
Cleared Apr 20, 2017
Penumbra 3D Revascularization Device
K162901 · NRY
Penumbra, Inc.
Neurology · 185d
Cleared Apr 17, 2017
Pressio 2 ICP Monitoring System
K162108 · GWM
Sophysa SA
Neurology · 262d
Cleared Apr 14, 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K162517 · NUH
Jkh Health Co., Ltd.
Neurology · 217d
Cleared Apr 14, 2017
Complete Control System
K162891 · GXY
Coapt, LLC
Neurology · 179d
Not Cleared Apr 14, 2017
gammaCore Non-invasive Vagus Nerve Stimulator
DEN150048 · PKR
Electrocore, LLC
Neurology · 546d
Cleared Apr 13, 2017
Coolief* Cooled RF Probe
K163461 · GXI
Halyard Health, Inc.
Neurology · 125d
Cleared Apr 12, 2017
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth...
K163355 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 133d
Cleared Apr 11, 2017
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96
K163547 · GXY
Neurovirtual USA, Inc.
Neurology · 116d
Cleared Apr 11, 2017
REMbrandt
K163617 · OLZ
Embla Systems
Neurology · 110d
Cleared Apr 05, 2017
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
K170677 · GWF
Neurovision Medical Product, Inc.
Neurology · 30d
Cleared Mar 31, 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · HAW
Medtronic Navigation, Inc.
Neurology · 226d
Cleared Mar 31, 2017
EnsoSleep
K162627 · OLZ
Ensodata, Inc.
Neurology · 192d
Cleared Mar 31, 2017
MEP Monitor
K162873 · GWF
Tonica Elektronik A/S
Neurology · 169d
Cleared Mar 29, 2017
V-Grip Detachment Controller for use with Hydrocoil Embolic System and...
K162999 · HCG
MicroVention, Inc.
Neurology · 152d
Cleared Mar 28, 2017
MR8 Drill System
K163565 · HBC
Medtronic Powered Surgical Solutions
Neurology · 99d
Cleared Mar 27, 2017
Cleveland Multiport Ventricular Catheter Set
K161731 · HCA
Parker Hannifin Corp.
Neurology · 277d
Cleared Mar 24, 2017
MEDICON Spinal Spreading Systems
K161680 · GZT
Medicon EG
Neurology · 280d
Cleared Mar 24, 2017
iovera system
K161835 · GXH
Myoscience, Inc.
Neurology · 262d
Cleared Mar 23, 2017
Eclipse with VEMP
K162037 · GWJ
Interacoustics A/S
Neurology · 244d
Cleared Mar 23, 2017
Medtronic Legend Pneumatic
K163182 · HBB
Medtronic Powered Surgical Solutions
Neurology · 129d
Cleared Mar 23, 2017
Synapsys Ulmer Video Nystagmograph
K163558 · GWN
Synapsys SA
Neurology · 94d