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
1753–1776 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 07, 2016
Symmetry Sharp Kerrison Rongeur
K161744 · HAE
Symmetry Surgical, Inc.
Neurology · 75d
Not Cleared Sep 02, 2016
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP...
DEN150049 · POL
Concentric Medical, Inc.
Neurology · 312d
Cleared Aug 31, 2016
HydroCoil Embolic System (HES)
K161367 · HCG
MicroVention, Inc.
Neurology · 106d
Cleared Aug 31, 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · HCG
MicroVention, Inc.
Neurology · 97d
Cleared Aug 26, 2016
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · GXI
Lccs Products Limited
Neurology · 346d
Cleared Aug 26, 2016
Freedom Spinal Cord Stimulator System
K160600 · GZB
Stimwave Technologies Incorporated
Neurology · 177d
Cleared Aug 23, 2016
sTMS mini
K161663 · OKP
Eneura, Inc.
Neurology · 68d
Not Cleared Aug 22, 2016
ImPACT Computerized Neurocognitive Concussion Management Aid
DEN150037 · POM
Impact Applications, Inc.
Neurology · 377d
Cleared Aug 19, 2016
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit,...
K153347 · GWM
Codman & Shurtleff, Inc.
Neurology · 273d
Cleared Aug 11, 2016
Adhesive Electrodes
K160138 · GXY
Gmdasz Manufacturing Co., Ltd.
Neurology · 203d
Cleared Aug 08, 2016
Cerafix Dura Substitute
K161278 · GXQ
Acera Surgical, Inc.
Neurology · 94d
Cleared Aug 04, 2016
Fehling-Punches
K153243 · HAE
Fehling Instruments GmbH & Co. KG
Neurology · 269d
Not Cleared Aug 01, 2016
Nautilus BrainPulse 1000
DEN140040 · POP
Jan Medical, Inc.
Neurology · 587d
Cleared Jul 27, 2016
HANAROCare ReJu
K160893 · NUH
M.I. Tech Co., Ltd.
Neurology · 118d
Cleared Jul 23, 2016
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads,...
K161154 · NHI
Spr Therapeutics, LLC
Neurology · 89d
Cleared Jul 22, 2016
ELAN 4 Motor System
K152960 · HBC
Aesculap, Inc.
Neurology · 289d
Cleared Jul 22, 2016
ReWalk(TM)
K160987 · PHL
Rewalk Robotics, Inc.
Neurology · 105d
Cleared Jul 20, 2016
St. Louis Band
K161138 · OAN
Orthomerica Products, Inc.
Neurology · 89d
Cleared Jul 19, 2016
Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
K161443 · PHL
Ekso Bionics, Inc.
Neurology · 55d
Not Cleared Jul 15, 2016
EPIC ClearView System
DEN150004 · PNA
Epic Research & Diagnostics, Inc.
Neurology · 549d
Cleared Jul 14, 2016
PMT Platinum Depthalon Depth Electrode
K151790 · GZL
Pmt Corporation
Neurology · 379d
Cleared Jul 13, 2016
EXACTECH GPS
K152764 · HAW
Blue Ortho
Neurology · 293d
Cleared Jul 12, 2016
Penumbra System ACE 68 Reperfusion Catheter
K161640 · NRY
Penumbra, Inc.
Neurology · 28d
Cleared CT Jul 09, 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · GXI
Relievant Medsystems
Neurology · 240d