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
217–240 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 31, 2025
GREEN
K252060 · HBE
Phasor Health, LLC
Neurology · 122d
Cleared Oct 31, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K252160 · OMB
Persyst Development, LLC
Neurology · 113d
Cleared Oct 30, 2025
Zoom System (Zoom 4S Catheter)
K252046 · NRY
Imperative Care, Inc.
Neurology · 122d
Cleared Oct 29, 2025
Medi Lift Essential Eye Mask
K250618 · NFO
Ya-Man, Ltd.
Neurology · 243d
Cleared Oct 27, 2025
TECHFIT Patient-Specific Cranial System
K250297 · GWO
Techfit Digital Surgery, Inc.
Neurology · 269d
Cleared CT Oct 24, 2025
Atalante X
K250904 · PHL
Wandercraft SAS
Neurology · 212d
Cleared Oct 24, 2025
VersaD Delivery Catheter
K251372 · QJP
Unity Medical, Inc.
Neurology · 175d
Cleared Oct 22, 2025
Carrier XL Delivery Catheter
K252569 · QJP
Balt USA, LLC
Neurology · 69d
Cleared Oct 21, 2025
NeuroAlign software
K231897 · HAW
Medivis, Inc.
Neurology · 846d
Cleared Oct 17, 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · NFO
Shenzhen Qianyu Technology Co., Ltd.
Neurology · 263d
Cleared Oct 17, 2025
InZone IST Detachment System
K251832 · HCG
Stryker Neurovascular
Neurology · 123d
Cleared Oct 12, 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70)
K251034 · NFO
Shenzhen Nuon Medical Equipment Co.,...
Neurology · 192d
Cleared Oct 10, 2025
Zeta Navigation System (ZNS131-US)
K251927 · SGE
Zeta Surgical, Inc.
Neurology · 109d
Cleared Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · OLT
Nihon Kohden Corporation
Neurology · 161d
Cleared Oct 09, 2025
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004,...
K252553 · NFO
Shenzhen Jianchao Intelligent...
Neurology · 57d
Cleared Oct 06, 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · NRY
Rapid Medical , Ltd.
Neurology · 132d
Not Cleared Oct 06, 2025
PainChek (PainChek Adult)
DEN240073 · SGB
Painchek Limited (Ltd.)
Neurology · 299d
Cleared Sep 29, 2025
allay Nerve Cap (TL5515-1)
K252051 · SBG
Tulavi Therapeutics, Inc.
Neurology · 90d
Cleared Sep 26, 2025
Optima Coil System (Optima Packing Coil System)
K252700 · HCG
Balt USA, LLC
Neurology · 30d
Cleared Sep 25, 2025
EMBOTRAP III Revascularization Device
K251789 · NRY
Neuravi Limited
Neurology · 106d
Cleared Sep 19, 2025
UniBur
K252662 · HBE
Nakanishi, Inc.
Neurology · 28d
Cleared Sep 18, 2025
Sunny Plus (Sunny)
K251649 · NFO
ShenB Co., Ltd.
Neurology · 112d
Cleared Sep 14, 2025
CloudTMS Edge
K250689 · OBP
Teleemg, LLC
Neurology · 192d
Cleared Sep 13, 2025
BrainsWay Deep TMS System
K251449 · OBP
Brainsway , Ltd.
Neurology · 127d