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
1249–1272 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 11, 2019
Electronic Pulse Stimulator
K183674 · NUH
Shenzhen Leading Perfection...
Neurology · 288d
Cleared Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume...
K191684 · JXG
Integra LifeSciences Corporation
Neurology · 109d
Cleared Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
K182136 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 430d
Cleared Oct 10, 2019
Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory –...
K190523 · PJN
Ossdsign AB
Neurology · 220d
Cleared Oct 10, 2019
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
K190772 · IZI
Olympus Medical Systems Corp.
Neurology · 198d
Cleared Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687 · DQX
Phenox Limited
Neurology · 107d
Cleared Sep 25, 2019
Mediracer NCS
K190536 · JXE
Mediracer OY
Neurology · 205d
Cleared Sep 21, 2019
Medi-Direct TENS Pen
K182671 · NUH
Jkh USA, LLC
Neurology · 360d
Cleared Sep 12, 2019
L360 Thigh System
K191587 · GZI
Bioness, Inc.
Neurology · 90d
Cleared CT Sep 11, 2019
BrainScope TBI
K190815 · PIW
Brainscope Company, Inc.
Neurology · 166d
Cleared Sep 11, 2019
Ceribell Pocket EEG Device
K191301 · OMB
Ceribell, Inc.
Neurology · 120d
Cleared Sep 07, 2019
Focus TENS Therapy, Model PM710-M/-L
K183215 · NUH
Omron Healthcare, Inc.
Neurology · 292d
Cleared Sep 06, 2019
Microscope Navigation
K190250 · HAW
Brainlab AG
Neurology · 211d
Cleared Sep 06, 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40...
K191435 · GZF
Nalu Medical, Inc.
Neurology · 99d
Cleared Sep 04, 2019
Myo Plus
K191179 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 125d
Cleared Aug 30, 2019
Artemis Eye System
K190719 · GWG
Penumbra, Inc.
Neurology · 163d
Cleared Aug 30, 2019
ReliefBand
K191547 · GZJ
Reliefband Technologies, LLC
Neurology · 79d
Cleared Aug 30, 2019
SelectFlex 072 Neurovascular Access System
K191664 · DQY
Q'Apel Medical
Neurology · 70d
Cleared Aug 28, 2019
PureLift
K190269 · NFO
Xtreem Pulse, LLC
Neurology · 201d
Cleared Aug 16, 2019
GIM-STIM OTC TENS/EMS System
K190988 · NUH
Gemore Technology Co, Ltd.
Neurology · 123d
Cleared Aug 09, 2019
ELAN 4 Tools
K183203 · HBE
Aesculap, Inc.
Neurology · 263d
Cleared Aug 05, 2019
EEG Electrode Template
K191225 · GXY
Rhythmlink International, LLC
Neurology · 90d
Cleared Aug 02, 2019
046 Zenith Flex
K190338 · NRY
Inneuroco, Inc.
Neurology · 169d
Cleared Aug 01, 2019
Mini TENS Therapy Device
K182871 · NUH
Shenzhen Jumper Medical Equipment...
Neurology · 293d