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
121–144 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared May 01, 2026
Zeta Navigation System
K253663 · HAW
Zeta Surgical, Inc.
Neurology · 162d
Cleared May 01, 2026
Tutamen Self Adhesive Electrodes
K252439 · GXY
Dongguan Tutamen Metalwork Co., Ltd.
Neurology · 270d
Cleared Apr 29, 2026
Aristotle 14 Guidewire
K253579 · MOF
Scientia Vascular, Inc.
Neurology · 163d
Cleared Apr 26, 2026
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S)
K253580 · PDQ
Tedan Surgical Innovations
Neurology · 160d
Cleared Apr 23, 2026
NeuroBlate System
K260976 · ONO
Monteris Medical,
Neurology · 30d
Cleared Apr 22, 2026
myosmart. (13E522)
K253256 · GXY
Otto Bock Healthcare Products GmbH
Neurology · 205d
Cleared Apr 21, 2026
BosCATH Support Catheter
K254046 · QJP
Sonorous NV, Inc.
Neurology · 125d
Cleared Apr 17, 2026
Wovyn Depth Electrode
K253970 · GZL
Sensomedical Labs, Ltd.
Neurology · 127d
Cleared Apr 16, 2026
Next Generation 088 Catheter
K254223 · QJP
Balt USA, LLC
Neurology · 108d
Cleared Apr 16, 2026
Enso for Migraine
K254216 · PCC
Hinge Health, Inc.
Neurology · 108d
Cleared Apr 16, 2026
Disposable Radiofrequency Cannula
K253907 · GXI
Abbott Medical
Neurology · 132d
Cleared Apr 16, 2026
Zenith Micro Guidewire
K252317 · MOF
Suzhou Zenith Vascular SciTech Limited
Neurology · 265d
Cleared Apr 15, 2026
PATH BGC
K260938 · QJP
Crossroads Neurovascular, Inc.
Neurology · 26d
Cleared Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
K252241 · GWM
Sophysa
Neurology · 267d
Cleared Apr 09, 2026
SILKBridge
K260245 · JXI
KLISBio S.r.l.
Neurology · 72d
Cleared Apr 09, 2026
Radical 6F Access Catheter
K253975 · QJP
Maduro Medical, Inc.
Neurology · 119d
Cleared Apr 09, 2026
EASYMADE-TI
K252251 · GXN
CG Bio Co., Ltd.
Neurology · 265d
Cleared Apr 03, 2026
Ceribell Brain Monitor Headband
K260363 · GXY
Ceribell, Inc.
Neurology · 58d
Not Cleared Apr 03, 2026
neuropacs
DEN240071 · SHO
Automated Imaging Diagnostics, LLC
Neurology · 485d
Cleared Mar 26, 2026
Surgify Halo (54.085.SHD.U1)
K253627 · HBE
Surgify Medical OY
Neurology · 127d
Cleared Mar 26, 2026
Stealth AXiS Cranial clinical application
K253379 · HAW
Medtronic Navigation, Inc.
Neurology · 177d
Cleared Mar 20, 2026
Noxturnal Web
K260585 · OLV
Nox Medical Ehf
Neurology · 28d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K253098 · OBP
Nexstim Oyj
Neurology · 178d
Cleared Mar 20, 2026
Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
K252358 · OBP
Nexstim Oyj
Neurology · 234d