FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
145–168 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared Oct 31, 2025
GREEN
K252060 · HBE
Phasor Health, LLC
Neurology · 122d
Cleared Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K251381 · GXY
Ceribell, Inc.
Neurology · 182d
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 Oct 24, 2025
VersaD Delivery Catheter
K251372 · QJP
Unity Medical, Inc.
Neurology · 175d
Cleared Oct 24, 2025
Atalante X
K250904 · PHL
Wandercraft SAS
Neurology · 212d
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
InZone IST Detachment System
K251832 · HCG
Stryker Neurovascular
Neurology · 123d
Cleared Oct 17, 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · NFO
Shenzhen Qianyu Technology Co., Ltd.
Neurology · 263d
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
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004,...
K252553 · NFO
Shenzhen Jianchao Intelligent...
Neurology · 57d
Cleared Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
K251366 · OLT
Nihon Kohden Corporation
Neurology · 161d
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