FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,291 results
1465–1488 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 22, 2018
Test of Variables of Attention (T.O.V.A.)
K173915 · LQD
The Tova Company
Neurology · 90d
Cleared Mar 21, 2018
Element System with IBT Electrodes
K173571 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 121d
Cleared Mar 18, 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · NRY
Stryker
Neurology · 90d
Cleared Mar 14, 2018
Natus NeuroWorks
K180421 · OMB
Natus Medical Incorporated Dba...
Neurology · 26d
Cleared Mar 09, 2018
L300 Go System
K173682 · GZI
Bioness, Inc.
Neurology · 98d
Cleared Mar 09, 2018
Grass TWin
K173690 · OLV
Natus Medical Incorporated Dba...
Neurology · 98d
Cleared Mar 08, 2018
Neuro Assessment System NAS-1000
K172892 · QBE
Headsense Medical, Inc.
Neurology · 167d
Cleared Mar 07, 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · NUH
Bayer Healthcare, LLC
Neurology · 261d
Cleared Mar 01, 2018
Microscope Navigation Software
K172820 · HAW
Brainlab AG
Neurology · 164d
Cleared Mar 01, 2018
STARband, STARlight, St. Louis Band
K180109 · OAN
Orthomerica Products, Inc.
Neurology · 44d
Cleared Feb 28, 2018
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050,...
K173186 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 149d
Cleared Feb 28, 2018
iovera system
K173763 · GXH
Myoscience, Inc.
Neurology · 79d
Cleared Feb 27, 2018
NeuroNav System, NeuroSmart System
K172042 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 236d
Cleared Feb 22, 2018
Natus Quantum
K180181 · GWQ
Natus Medical Incorporated Dba...
Neurology · 30d
Cleared Feb 18, 2018
Optima Coil System
K172390 · HCG
Blockade Medical, LLC (D.B.A. Balt Usa)
Neurology · 194d
Cleared Feb 16, 2018
NeuroEEG
K173460 · GWQ
Memory MD, Inc.
Neurology · 101d
Cleared Feb 15, 2018
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
K173352 · POL
Concentric Medical, Inc.
Neurology · 113d
Cleared Feb 15, 2018
AtriCure cryoICE cryo-ablation probe (CRYO2)
K180138 · GXH
AtriCure, Inc.
Neurology · 29d
Cleared Feb 01, 2018
Micromed BRAIN QUICK system
K171384 · GWQ
Micromed S.P.A.
Neurology · 266d
Cleared Jan 31, 2018
ODFS Pace XL
K171396 · GZI
Odstock Medical, Ltd.
Neurology · 265d
Cleared Jan 31, 2018
Indego(R)
K173530 · PHL
Parker Hannifin Corporation
Neurology · 77d
Cleared Jan 26, 2018
SedLine Sedation Monitor
K172890 · OLW
Masimo Corporation
Neurology · 126d
Cleared Jan 26, 2018
Embrace
K172935 · POS
Empatica S.R.L.
Neurology · 122d
Cleared Jan 23, 2018
gammaCore-S
K173442 · PKR
Electrocore, LLC
Neurology · 78d