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
1177–1200 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 31, 2020
iCEWav Neuromonitoring Platform
K191868 · GWQ
Ice Neurosystems, Inc.
Neurology · 263d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482 · GZF
Bioness, Inc.
Neurology · 29d
Cleared Mar 26, 2020
gammaCore Sapphire
K191830 · PKR
Electrocore, Inc.
Neurology · 261d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Mar 23, 2020
Somryst
K191716 · QVO
Pear Therapeutics, Inc.
Neurology · 271d
Cleared Mar 17, 2020
NeuralScan System
K192753 · GWQ
Medeia, Inc.
Neurology · 169d
Cleared Mar 14, 2020
Health Expert Electronic Stimulator (model: AST-300L)
K190783 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 353d
Cleared Mar 13, 2020
NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC...
K192162 · GXR
Neurovention, LLC
Neurology · 217d
Cleared Mar 04, 2020
TumEase Acupressure Bracelets
K193374 · MVV
Mumease
Neurology · 90d
Cleared Mar 04, 2020
L100 Go System
K200262 · GZI
Bioness, Inc.
Neurology · 30d
Cleared Feb 27, 2020
Penumbra System Penumbra JET 7X
K191946 · NRY
Penumbra, Inc.
Neurology · 220d
Cleared Feb 27, 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA...
K192804 · QJP
Medos International SARL
Neurology · 149d
Cleared Feb 27, 2020
AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
K200206 · QJP
Stryker Neurovascular
Neurology · 30d
Cleared Feb 21, 2020
DORO LUCENT® iXI and iMRI Headrest System
K191740 · HBL
Pro-Med Instruments GmbH
Neurology · 235d
Cleared Feb 21, 2020
Coolief Radiofrequency Generator (CRG) System
K192491 · GXD
Avanos Medical, Inc.
Neurology · 163d
Cleared Feb 20, 2020
ApneaTrak
K192624 · OLV
Cadwell Industries, Inc.
Neurology · 150d
Cleared Feb 14, 2020
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · GYC
Blackrock Microsystems
Neurology · 270d
Cleared Feb 14, 2020
Orion LifeSpan MEG
K191785 · OLY
Compumedics Limited
Neurology · 226d
Cleared Feb 13, 2020
ClearPoint System and Accessories
K200079 · HAW
Mri Interventions, Inc.
Neurology · 30d
Cleared Feb 07, 2020
Vesta RF Cannula
K190259 · GXI
Biomerics
Neurology · 365d
Cleared Feb 07, 2020
Elefix V Paste for EEG & EMG
K191975 · GYB
Nihon Kohden Corporation
Neurology · 198d
Cleared Feb 07, 2020
Trevo NXT ProVue Retriever
K200117 · POL
Stryker
Neurology · 17d
Cleared Feb 01, 2020
Optima Coil System
K200030 · HCG
Balt USA, LLC
Neurology · 25d
Cleared Jan 30, 2020
Neo
K192889 · OMA
Eemagine Medical Imaging Solutions GmbH
Neurology · 112d