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
1537–1560 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 25, 2017
ISEN-Goggles with Data Viewer
K163270 · GWN
Isent Tech & Trading Company, Ltd.
Neurology · 308d
Cleared Sep 25, 2017
GALAXY G3 Mini Microcoil Delivery System
K171862 · HCG
Codman & Shurtleff, Inc.
Neurology · 95d
Cleared Sep 22, 2017
WiTouch Pro, WiTouch, Neubac
K171599 · NUH
Hollywog, LLC
Neurology · 113d
Cleared Sep 21, 2017
Persyst Mobile App
K171184 · OMB
Persyst Development Corporation
Neurology · 150d
Cleared Sep 19, 2017
Pain Therapy Device
K163611 · NUH
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 271d
Cleared Sep 15, 2017
neuro inspire
K163666 · HAW
Rensihaw Plc
Neurology · 262d
Cleared Sep 15, 2017
Leksell Vantage Stereotactic System
K171123 · HAW
Elekta Instrument AB
Neurology · 151d
Cleared Sep 15, 2017
Cefaly Acute
K171446 · PCC
Cefaly Technology
Neurology · 122d
Cleared Sep 14, 2017
Fiagon Navigation System
K163209 · HAW
Fiagon GmbH
Neurology · 303d
Not Cleared Sep 14, 2017
reSet
DEN160018 · PWE
Pear Therapeutics, Inc.
Neurology · 486d
Cleared Sep 13, 2017
HORIZON Therapy System
K171051 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Sep 11, 2017
Sterile NS System
K170368 · GWO
Jeil Medical Corporation
Neurology · 217d
Cleared Sep 08, 2017
Indego
K171334 · PHL
Parker Hannifin Corporation
Neurology · 123d
Cleared Sep 07, 2017
Cranial Drill Bits and Accessories
K170442 · HBE
Ad-Tech Medical Instrument Corporation
Neurology · 205d
Cleared Sep 07, 2017
NICO BrainPath
K172433 · GZT
Nico Corporation
Neurology · 27d
Cleared Sep 06, 2017
QuadraSphere Microspheres
K172372 · KRD
Biosphere Medical, S.A.
Neurology · 30d
Cleared Sep 01, 2017
NaviENT
K163439 · HAW
Claronav, Inc.
Neurology · 267d
Cleared Sep 01, 2017
GrindCare System
K163448 · HCC
Sunstar Suisse S.A.
Neurology · 267d
Cleared Sep 01, 2017
CustomizedBone Service
K171507 · GXN
Fin-Ceramica Faenza S.P.A.
Neurology · 101d
Cleared Aug 31, 2017
SureFlo EVD Catheter
K170599 · JXG
Arkis Biosciences, Inc.
Neurology · 183d
Cleared Aug 30, 2017
MyndMove System, MyndMove Functional Electrical Stimulator
K170564 · GZI
Myndtec, Inc.
Neurology · 184d
Cleared Aug 25, 2017
Nihon Kohden Wireless Input Unit WEE-1200
K171124 · GWQ
Nihon Kohden Corporation
Neurology · 130d
Cleared Aug 21, 2017
Ceribell Instant EEG Headband
K171459 · GXY
Ceribell, Inc.
Neurology · 95d
Cleared Aug 18, 2017
QEVO System with KINEVO 900
K170667 · GWG
Carl Zeiss Meditec, AG
Neurology · 165d