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
793–816 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Sep 14, 2022
iRelieve Microcurrent Pain Relief System
K212618 · GZJ
Fast Track Technologies, Inc.
Neurology · 392d
Cleared Sep 13, 2022
Transcutaneous Electrical Nerve Stimulator Model: ST-304
K221092 · NUH
Shenzhen Future Electronic Co., Ltd.
Neurology · 153d
Cleared CT Sep 13, 2022
Primary Relief
K221425 · NHI
Dyansys, Inc.
Neurology · 120d
Cleared Sep 12, 2022
SOFIA 88 Catheter
K214024 · DQY
MicroVention, Inc.
Neurology · 264d
Cleared Sep 09, 2022
Dexus Prosthetics System (Model: MSL1, MSR1)
K220002 · GXY
Zhejiang Qiangnao Technology Co.,Ltd
Neurology · 248d
Cleared Sep 08, 2022
Cranial EM System
K213989 · HAW
Brainlab AG
Neurology · 262d
Cleared Sep 07, 2022
Matreneu Percutaneous Balloon Compression Kit
K220920 · HAO
Shenzhen Shineyard Medical Device Co....
Neurology · 161d
Cleared CT Sep 01, 2022
Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
K220177 · OBP
Magnus Medical, Inc.
Neurology · 223d
Cleared Sep 01, 2022
Wireless TENS/EMS, Bruno, Aela
K220997 · NUH
Zmi Elecronics , Ltd.
Neurology · 150d
Cleared Aug 26, 2022
StimOnTM Pain Relief System (GM2439)
K213802 · GZJ
Gimer Medical Co., Ltd.
Neurology · 263d
Cleared Aug 26, 2022
MedCAD AccuShape Titanium Patient-Specific Cranial Implant
K220357 · GXN
Medcad
Neurology · 199d
Cleared CT Aug 26, 2022
BrainsWay Deep TMS System
K220819 · OBP
Brainsway , Ltd.
Neurology · 158d
Cleared Aug 24, 2022
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System,...
K222230 · OBP
Neuronetics, Inc.
Neurology · 30d
Cleared Aug 23, 2022
2.1 x 255mm Drill, 22mm Stop
K213072 · HBE
Biomet Micofixation
Neurology · 334d
Cleared Aug 18, 2022
Benchmark BMX96 Access System
K213390 · QJP
Penumbra, Inc.
Neurology · 307d
Cleared Aug 17, 2022
Disposable Brain Biopsy Needle 2.0
K220897 · HAW
PAJUNK GmbH Medizintechnologie
Neurology · 142d
Cleared Aug 10, 2022
iSyncWave
K220056 · GWQ
iMediSync, Inc.
Neurology · 216d
Cleared Aug 04, 2022
Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)
K220524 · NUH
Well-Life Healthcare Limited
Neurology · 162d
Cleared Jul 29, 2022
091 Balloon Guide Catheter
K220331 · DQY
Inneuroco, Inc.
Neurology · 175d
Cleared Jul 29, 2022
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K221251 · NUH
Guangzhou Huakai Electronic...
Neurology · 88d
Cleared Jul 25, 2022
Tigertriever 13 Revascularization Device
K220808 · NRY
Rapid Medical , Ltd.
Neurology · 129d
Cleared Jul 22, 2022
BLUE 400
K211346 · QFX
Carl Zeiss Meditec, AG
Neurology · 445d
Cleared Jul 19, 2022
MAGIC Flow-Dependent Microcatheter
K213435 · KRA
Balt USA, LLC
Neurology · 270d
Cleared Jul 15, 2022
Nerve Tape
K210665 · JXI
Biocircuit Technologies, Incorporated
Neurology · 497d