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
1705–1728 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 15, 2016
TEMPEDY
K152946 · NCX
Seiratherm GmbH
Neurology · 345d
Cleared Sep 15, 2016
HBOTC Muscle and Nerve Stimulator
K160255 · NUH
Hb Medical, Inc.
Neurology · 227d
Cleared Sep 14, 2016
StealthStation System with Cranial Software
K153660 · HAW
Medtronic Navigation, Inc.
Neurology · 268d
Cleared Sep 11, 2016
NeuroStar TMS Therapy System
K161519 · OBP
Neuronetics, Inc.
Neurology · 101d
Cleared Sep 09, 2016
Self-retaining Retractor
K161004 · GZT
Fetzer Medical GmbH & Co. KG
Neurology · 151d
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