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
1417–1440 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Sep 26, 2018
Everyway Wireless TENS & EMS Unit
K181707 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Sep 19, 2018
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · GZB
Stimwave Technologies Incorporated
Neurology · 159d
Cleared Sep 15, 2018
ThermaCare Quick Therapy TENS
K181102 · NUH
Pfizer, Inc.
Neurology · 142d
Cleared Sep 14, 2018
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369 · GXI
Relievant Medsystems
Neurology · 214d
Cleared Sep 13, 2018
TENS device-HeadaTerm, eEspress
K172450 · PCC
Wat Medical Technology (Ningbo) Co.,...
Neurology · 395d
Cleared Sep 13, 2018
SelectFlex 072 Neurovascular Access System
K181000 · DQY
Q'Apel
Neurology · 150d
Cleared Sep 07, 2018
GLOW800
K181537 · IZI
Leica Microsystems (Schweiz) AG
Neurology · 88d
Cleared Sep 06, 2018
Dual output digital therapy massager
K172834 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 352d
Cleared Sep 01, 2018
Cadwell Zenith System
K181466 · GWQ
Cadwell Industries, Inc.
Neurology · 89d
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · POL
Medtronic Neurovascular
Neurology · 123d
Cleared Aug 23, 2018
Freespira
K180173 · HCC
Palo Alto Health Sciences, Inc.
Neurology · 213d
Cleared Aug 22, 2018
NIM PAK Needle
K180542 · PDQ
Boston Endo Surgical Tech,
Neurology · 174d
Cleared Aug 17, 2018
Optical Topography System ETG-4100
K172492 · DQA
Hitachi Healthcare Americas
Neurology · 365d
Cleared Aug 17, 2018
Penumbra System Reperfusion Catheter JET 7
K173761 · NRY
Penumbra, Inc.
Neurology · 249d
Cleared Aug 17, 2018
BioWaveGO
K180943 · GZJ
Biowave Corporation
Neurology · 129d
Not Cleared Aug 17, 2018
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
DEN170078 · QCI
Brainways , Ltd.
Neurology · 322d
Cleared Aug 14, 2018
Mag Vita TMS Therapy System w/Theta Burst Stimulation
K173620 · OBP
Tonica Elektronik A/S
Neurology · 265d
Cleared Aug 10, 2018
iStim S2 OTC Pain Relief TENS
K181849 · NUH
Everyway Medical Instruments Co., Ldt.
Neurology · 30d
Cleared Aug 09, 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 58d
Cleared Aug 08, 2018
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay...
K180169 · DQY
Imperative Care, Inc.
Neurology · 198d
Cleared Aug 08, 2018
7D Surgical System Cranial Application
K181041 · HAW
7D Surgical, Inc.
Neurology · 111d
Cleared Aug 07, 2018
Self-adhesive Electrode
K181234 · GXY
Dong Guan OU Kang Electronics Co., Ltd.
Neurology · 90d