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
313–336 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · HAW
Brainlab AG
Neurology · 60d
Cleared Jan 24, 2025
ClearPoint System (Software Version 3.0)
K243657 · HAW
ClearPoint Neuro, Inc.
Neurology · 58d
Cleared Jan 23, 2025
RF Cannula
K241367 · GXI
Shanghai Samedical & Plastic...
Neurology · 254d
Cleared Jan 22, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K242446 · OMB
Persyst Development Corporation
Neurology · 159d
Cleared Jan 22, 2025
Nicolet EDX
K243982 · GWF
Natus Neurology Incorporated
Neurology · 30d
Cleared Jan 17, 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 252d
Cleared Jan 17, 2025
VersaD Delivery Catheter
K242051 · QJP
Unity Medical, Inc.
Neurology · 189d
Cleared Jan 16, 2025
ADDNOX (BPSPM1)
K243289 · QGL
Nu Eyne Co., Ltd.
Neurology · 90d
Cleared Jan 16, 2025
Cala kIQ
K243848 · QBC
Cala Health, Inc.
Neurology · 31d
Cleared Jan 16, 2025
Medi Lift Mask
K244048 · NFO
Ya-Man, Ltd.
Neurology · 16d
Cleared Jan 15, 2025
Electrode Pad
K241512 · GXY
Shenzhen Deliduo Medical Technology...
Neurology · 231d
Cleared Jan 14, 2025
Zoom System
K242672 · NRY
Imperative Care, Inc.
Neurology · 130d
Cleared Jan 14, 2025
APRO 70 Swift Catheter
K243297 · QJP
Alembic, LLC
Neurology · 88d
Cleared Jan 14, 2025
Radical the Dude 8F Guide Catheter
K243577 · QJP
Maduro Medical, Inc.
Neurology · 56d
Cleared Jan 08, 2025
DormoTech NLab
K242290 · MNR
Dormotech Medical, Ltd.
Neurology · 159d
Cleared Jan 06, 2025
Mobility Scooter (YL-09B, YL-07)
K242139 · INI
Yongkang Yile Vehicle Co., Ltd.
Neurology · 168d
Cleared Jan 02, 2025
Rist 079 Radial Access Guide Catheter
K241388 · QJP
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 232d
Cleared Jan 02, 2025
Wave Electrode (AE02-60)
K242326 · GXY
Bionit Labs Srl
Neurology · 149d
Cleared Dec 30, 2024
Next Generation Access Platform
K242376 · QJP
Balt USA, LLC
Neurology · 143d
Cleared Dec 27, 2024
FLASH EVD System (10-0002)
K242480 · HAW
7D Surgical ULC
Neurology · 128d
Cleared Dec 26, 2024
iovera° System
K243677 · GXH
Pacira Biosciences, Inc.
Neurology · 29d
Cleared Dec 23, 2024
Noxturnal Web
K241288 · OLV
Nox Medical Ehf
Neurology · 230d
Cleared Dec 19, 2024
Echo Intracranial Base Catheter
K241637 · QJP
Stryker Neurovascular
Neurology · 195d
Cleared Dec 19, 2024
Broadway 8 Catheter
K241768 · QJP
Stryker Neurovascular
Neurology · 182d