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
553–576 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 CT 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
Cleared Dec 27, 2023
Nurochek-II System
K231914 · PIW
Headsafe Mfg Pty, Ltd.
Neurology · 181d
Cleared Dec 22, 2023
Distal Access Catheter
K233205 · QJP
Shanghai Heartcare Medical Technology...
Neurology · 85d
Cleared Dec 22, 2023
CloudTMS Edge for OCD
K233742 · QCI
Teleemg, LLC
Neurology · 30d
Cleared Dec 20, 2023
EMS Neck Massager
K233492 · NGX
Xiamen Comfier Technology Co., Ltd.
Neurology · 51d
Cleared Dec 19, 2023
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode,...
K221199 · GXY
Green Island International Tcm Group...
Neurology · 602d
Cleared Dec 19, 2023
Bactiseal EVD Catheter Sets
K233448 · JXG
Integra Lifesciences Production...
Neurology · 60d
Cleared Dec 15, 2023
Ova+ (K-OVAP-USA)
K230926 · NUH
Tenscare, Ltd.
Neurology · 256d