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
481–504 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Feb 08, 2024
Vecttor VT-300
K231575 · LIH
Artaflex, Inc.
Neurology · 253d
Cleared Feb 04, 2024
X-trodes System M
K232210 · GWL
X-Trodes
Neurology · 193d
Cleared Feb 04, 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · GWM
Integra Lifesciences Production...
Neurology · 139d
Cleared Feb 01, 2024
BTL-99-OC
K230657 · QCI
BTL Industries, Inc.
Neurology · 329d
Cleared Jan 29, 2024
Rebuilder Nerve Guidance Conduit
K230794 · JXI
Celestray Biotech Company, LLC.,
Neurology · 313d
Cleared Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G,...
K231423 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 250d
Cleared Jan 19, 2024
Distal Access Catheter
K231218 · QJP
Accumedical Beijing , Ltd.
Neurology · 266d
Cleared Jan 19, 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461 · NUH
Hi-Dow International, Inc.
Neurology · 88d
Cleared Jan 17, 2024
Bactiseal Catheters
K233445 · JXG
Integra Lifesciences Production...
Neurology · 90d
Cleared Jan 17, 2024
Cerenovus Large Bore Catheter
K233988 · NRY
Cerenovus, Inc.
Neurology · 30d
Cleared Jan 16, 2024
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
K233293 · QGL
Neurosigma, Inc.
Neurology · 109d
Cleared Jan 12, 2024
SmartFrame OR
K233141 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
ClearPoint Bone Screw Fiducials
K233144 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
ClearPointer Optical Navigation Wand
K233155 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 11, 2024
Neurological Therapy Devices - Accessories: Electrotherapy device Electrode...
K232995 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 111d
Not Cleared Jan 11, 2024
BrainSee
DEN220066 · QWT
Darmiyan, Inc.
Neurology · 469d
Cleared Jan 10, 2024
Numen Coil Embolization System
K232955 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 111d
Cleared Jan 10, 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · HAW
Zeta Surgical, Inc.
Neurology · 30d
Cleared Jan 08, 2024
Electronic Muscle Stimulator (Model MP01)
K233035 · NGX
Shenzhen Hengbosi Industrial Co., Ltd.
Neurology · 105d
Cleared Jan 07, 2024
autoSCORE
K231068 · OMB
Holberg Eeg AS
Neurology · 268d
Cleared Jan 03, 2024
REMI AI Discrete Detection Module
K231779 · OMB
Epitel, Inc.
Neurology · 201d
Cleared Dec 29, 2023
NQ TMS for MDD (NQv1-MU-01)
K232688 · OBP
Neuroqore, Inc.
Neurology · 119d
Cleared Dec 28, 2023
Ankyras
K230006 · PZO
Mentice Spain S.L.
Neurology · 359d
Cleared Dec 28, 2023
EvoWalk 1.0 System
K230997 · GZI
Evolution Devices, Inc.
Neurology · 265d