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
1129–1152 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · QJP
Route 92 Medical, Inc.
Neurology · 88d
Cleared Apr 16, 2020
Traxcess 14 SELECT Guidewire
K200547 · MOF
MicroVention, Inc.
Neurology · 44d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Apr 06, 2020
Neural Navigator
K191422 · HAW
Soterix Medical, Inc.
Neurology · 313d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access...
K192558 · DQY
Mivi Neurovascular
Neurology · 202d
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