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
937–960 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 21, 2021
Legend Pro DMA
K200545 · NGX
Pollogen, Ltd.
Neurology · 597d
Cleared Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
K211403 · NUH
Hivox Biotek, Inc.
Neurology · 162d
Cleared Oct 13, 2021
SPRINT PNS System
K211801 · NHI
Spr Therapeutics, Inc.
Neurology · 125d
Cleared Oct 13, 2021
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
K212908 · NRY
Neuravi, Ltd.
Neurology · 30d
Cleared Oct 08, 2021
B4C System
K201989 · GWM
Braincare Desenvolvimento E Inovacao...
Neurology · 448d
Cleared Oct 06, 2021
Adhesive Electrodes
K212191 · GXY
Voncare Medical Device Co., Ltd.
Neurology · 86d
Cleared Oct 05, 2021
Cala Trio
K203288 · QBC
Cala Health, Inc.
Neurology · 330d
Cleared Oct 04, 2021
Smart Neck Stimulator
K200558 · NUH
Guandong Skg Intelligent Technology...
Neurology · 580d
Cleared Oct 02, 2021
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · GYC
Dixi Medical
Neurology · 446d
Cleared Oct 02, 2021
EYE-SYNC
K202927 · QEA
Syncthink, Inc.
Neurology · 368d
Cleared Oct 01, 2021
OSSDSIGN Cranial PSI
K212414 · PJN
Ossdsign AB
Neurology · 59d
Cleared Sep 29, 2021
TheraFace Microcurrent
K212238 · NFO
Theragun, Inc.
Neurology · 72d
Cleared Sep 28, 2021
SoftSpot
K212045 · QQO
Pediametrix, Inc.
Neurology · 90d
Cleared Sep 23, 2021
LED PHOTIC System
K211974 · GWE
Micromed S.P.A.
Neurology · 90d
Cleared Sep 23, 2021
ZIIP+ Device
K212342 · NFO
Ziip, Inc.
Neurology · 57d
Cleared Sep 20, 2021
TracStar LDP Large Distal Platform
K212224 · QJP
Imperative Care, Inc.
Neurology · 66d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641 · JXG
Medtronic Neurosurgery
Neurology · 27d
Cleared Sep 14, 2021
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K211389 · OBP
Magstim Company, Ltd.
Neurology · 132d
Cleared Sep 10, 2021
Iovera System
K211334 · GXH
Pacira Pharmaceuticals, Inc.
Neurology · 130d
Cleared Sep 10, 2021
gammaCore Sapphire
K211856 · PKR
Electrocore, Inc.
Neurology · 86d
Cleared Sep 08, 2021
Longeviti ClearFit™ OTS Cranial Implants
K212058 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 69d
Cleared Sep 05, 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T,...
K211736 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 90d
Cleared Sep 01, 2021
Numen Coil Embolization System
K203625 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 264d
Cleared Sep 01, 2021
Evo sEEG System
K211367 · GZL
Neuroone Medical Technologies Corp.
Neurology · 120d