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
1585–1608 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 CT 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 CT 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 CT 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
Cleared Aug 18, 2017
Relievant Medsystems RF Generator
K171143 · GXD
Relievant Medsystems
Neurology · 122d
Cleared Aug 14, 2017
Artemis Neuro Evacuation Device
K171332 · GWG
Penumbra, Inc.
Neurology · 98d
Cleared Aug 11, 2017
EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
K163166 · NUH
Easywell Biomedicals, Inc.
Neurology · 270d
Cleared Aug 09, 2017
INTRACEPT Intraosseous Nerve Ablation System
K170827 · GXI
Relievant Medsystems
Neurology · 142d
Cleared Aug 08, 2017
AxoGen Nerve Cap
K163446 · JXI
Axogen Corporation
Neurology · 243d