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
1297–1320 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jun 19, 2019
MHD TENS
K190115 · NUH
Minghuangda Electronic Co., Ltd.
Neurology · 146d
Cleared Jun 18, 2019
Stryker MIS and Footed Attachments
K191049 · HBE
Stryker Corporation
Neurology · 60d
Cleared Jun 16, 2019
Penumbra System Reperfusion Catheter JET 7
K190010 · NRY
Penumbra, Inc.
Neurology · 164d
Cleared Jun 14, 2019
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K190172 · HBE
Stryker
Neurology · 133d
Cleared Jun 14, 2019
ELECTRODES PAD
K190700 · GXY
Shenzhen Bestpad Technology...
Neurology · 88d
Cleared Jun 13, 2019
XenoSure Dura Biologic Patch
K183513 · GXQ
LeMaitre Vascular, Inc.
Neurology · 177d
Cleared Jun 12, 2019
Avid IF2
K183692 · LIH
Vision Quest Industries Inc./Dba VQ...
Neurology · 163d
Cleared Jun 07, 2019
Masimo O3 Regional Oximeter System
K182429 · MUD
Masimo Corporation
Neurology · 274d
Not Cleared Jun 07, 2019
IB-Stim
DEN180057 · QHH
Innovative Health Solutions (Ihs), Inc.
Neurology · 225d
Cleared CT Jun 03, 2019
ReWalk Restore
K190337 · PHL
Re Walk Robotics , Ltd.
Neurology · 109d
Cleared May 31, 2019
NeuroShield
K190246 · JXI
Monarch Bioimplants GmbH
Neurology · 114d
Cleared May 24, 2019
COMPLETE CONTROL System Gen2
K191083 · GXY
Coapt, LLC
Neurology · 30d
Cleared May 21, 2019
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
K182711 · GWO
Kelyniam Global, Inc.
Neurology · 236d
Not Cleared May 20, 2019
Nerivio Migra
DEN180059 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 195d
Cleared May 15, 2019
SOFIA EX Intracranial Support Catheter
K182602 · DQY
MicroVention, Inc.
Neurology · 236d
Cleared May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515 · HBC
Medtronic Powered Surgical Solutions
Neurology · 145d
Cleared May 11, 2019
SPEAC System
K182180 · POS
Brain Sentinel, Inc.
Neurology · 271d
Cleared May 09, 2019
ATEC IOM Accessory Instruments
K182617 · PDQ
Alphatec Spine, Inc.
Neurology · 227d
Cleared May 03, 2019
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept...
K190504 · GXI
Relievant Medsystems
Neurology · 63d
Cleared May 01, 2019
Synchro2 Support Guidewire
K190843 · MOF
Stryker
Neurology · 30d
Cleared Apr 30, 2019
Eclipse 2L
K183045 · MJN
Balt USA, LLC
Neurology · 179d
Cleared Apr 26, 2019
Portable Electro-Stimulation Therapy Device
K182108 · NUH
Guangzhou Longest Science &...
Neurology · 266d
Cleared Apr 26, 2019
Penumbra System 3D Revascularization Device
K190464 · NRY
Penumbra, Inc.
Neurology · 59d
Cleared Apr 24, 2019
AXS Vecta Aspiration System
K190212 · NRY
Stryker Neurovascular
Neurology · 79d