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
193–216 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 03, 2025
Bendit17 Microcatheter
K252213 · QJP
Bend IT Technologies, Ltd.
Neurology · 141d
Cleared Dec 03, 2025
HippoMind (v1.0)
K251881 · OLT
Hippoclinic
Neurology · 168d
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636 · JXG
Sophysa
Neurology · 270d
Cleared Nov 26, 2025
0.014” Willow Guidewire
K253168 · MOF
Arbor Endovascular, LLC
Neurology · 61d
Cleared Nov 25, 2025
NX01 (NX01)
K251550 · OMC
Naox Technologies Sas
Neurology · 188d
Cleared Nov 24, 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · NUH
Bozhou Rongjian Medical Appliance...
Neurology · 90d
Cleared Nov 21, 2025
LEGACY
K252696 · HBG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 21, 2025
Ceribell Infant Seizure Detection Software
K252070 · OMB
Ceribell, Inc.
Neurology · 143d
Cleared Nov 21, 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 157d
Cleared Nov 21, 2025
Nelli (Version 7.11)
K251506 · POS
Neuro Event Labs OY
Neurology · 189d
Cleared Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
K251191 · GXQ
Collagen Matrix, Inc.
Neurology · 215d
Cleared Nov 17, 2025
DeepRESP
K252330 · OLZ
Nox Medical Ehf
Neurology · 115d
Cleared Nov 14, 2025
ARC-EX System
K251821 · SDO
Onward Medical, Inc.
Neurology · 154d
Not Cleared Nov 14, 2025
Neurolyser XR (NXR100)
DEN250015 · SGN
Fusmobile, Inc.
Neurology · 203d
Cleared Nov 12, 2025
Synthes Patient Specific Implants
K243715 · GXN
Synthes GmbH
Neurology · 345d
Cleared Nov 10, 2025
KLS Martin Cranial Implants - MR Conditional
K252573 · GXN
KLS-Martin L.P.
Neurology · 88d
Cleared Nov 10, 2025
NeVasc Aspiration System
K251006 · NRY
Vesalio, Inc.
Neurology · 223d
Cleared Nov 07, 2025
BrainsWay Deep TMS System
K251391 · OBP
Brainsway , Ltd.
Neurology · 186d
Cleared Nov 07, 2025
Triathlon Pro
K243131 · NUH
Sigma Biomedical
Neurology · 403d
Cleared Nov 06, 2025
Hubly Drill (H100)
K250815 · HBE
Hubly, Inc.
Neurology · 234d
Cleared Nov 06, 2025
mb-FIX Cranial Stabilization Systems
K250423 · HBL
Medical Bees GmbH
Neurology · 265d
Cleared Nov 05, 2025
EVAC-MRI
K252514 · JXG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 05, 2025
Depth Electrode (RSDE-08)
K250363 · GZL
Beijing Sinovation Medical Technology...
Neurology · 268d
Cleared Oct 31, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K252160 · OMB
Persyst Development, LLC
Neurology · 113d