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
361–384 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Not Cleared Nov 13, 2024
SmartFlow Neuro Cannula
DEN240023 · SDG
ClearPoint Neuro, Inc.
Neurology · 175d
Cleared Nov 12, 2024
pNOVUS 21 Microcatheter
K242420 · DQO
Phenox, Ltd.
Neurology · 89d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719 · PCC
Nu Eyne Co., Ltd.
Neurology · 57d
Cleared Nov 05, 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341,...
K242332 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 90d
Cleared Nov 05, 2024
Delphi Stimulator
K242345 · GWF
Quantalx Neuroscience
Neurology · 90d
Cleared Oct 29, 2024
Riptide Aspiration System
K243080 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 29d
Cleared Oct 29, 2024
AtriCure cryoICE BOX (ACM)
K243157 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 18, 2024
Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator
K233054 · NUH
Well-Life Healthcare Limited
Neurology · 389d
Cleared Oct 17, 2024
REMI-AI Rapid Detection Module (REMI-AI RDM)
K240408 · OMB
Epitel, Inc.
Neurology · 251d
Cleared Oct 17, 2024
Zipline Access Catheter
K240711 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Oct 16, 2024
Cerebral Autoregulation Index (CAI) Algorithm
K240596 · MUD
Edwards Lifesciences
Neurology · 226d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241221 · NRY
Cerenovus, Inc.
Neurology · 168d
Cleared Oct 16, 2024
CEREGLIDE 42 Intermediate Catheter
K241244 · QJP
Cerenovus, Inc.
Neurology · 167d
Cleared Oct 11, 2024
QUEX ED
K232779 · OMC
Qx World, Ltd.
Neurology · 396d
Cleared Oct 08, 2024
Nerivio
K241756 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 112d
Cleared Oct 04, 2024
Zeta Cranial Navigation System (ZNS131-US)
K242351 · HAW
Zeta Surgical, Inc.
Neurology · 57d
Cleared Oct 02, 2024
8F Modified Sheath System
K240529 · QJP
Route 92 Medical, Inc.
Neurology · 222d
Cleared Oct 01, 2024
Esperance 3+ Aspiration Catheter System
K240917 · NRY
Wallaby Medical
Neurology · 181d
Cleared Sep 30, 2024
Numen™ Coil Embolization System
K242154 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 69d
Cleared Sep 27, 2024
encevis (2.1)
K240993 · OMB
Ait Austrian Institute of Technology...
Neurology · 169d
Cleared Sep 27, 2024
Sourcerer
K241513 · OLX
Brain Electrophysiology Laboratory...
Neurology · 121d
Cleared Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · HCG
Balt USA, LLC
Neurology · 28d
Cleared Sep 26, 2024
Permatage Settable Bone Putty
K241027 · GXP
Orthocon, Inc.
Neurology · 164d