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
1009–1032 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 29, 2021
Disposable Pre-calibrated Suction
K201752 · HAW
Brainlab AG
Neurology · 217d
Cleared Jan 29, 2021
MAGIC Infusion Catheter
K202366 · KRA
Balt USA, LLC
Neurology · 163d
Cleared Jan 28, 2021
BOSS 8F Balloon Guide Catheter
K203840 · QJP
Marblehead Medical, LLC
Neurology · 28d
Cleared Jan 22, 2021
NuFace Trinity Plus Device
K201782 · NFO
Carol Cole Company Dba Nuface
Neurology · 206d
Cleared Jan 22, 2021
ClearPoint Array System
K202575 · HAW
ClearPoint Neuro, Inc.
Neurology · 140d
Cleared Jan 22, 2021
SPRINT PNS System
K202660 · NHI
Spr Therapeutics, Inc.
Neurology · 130d
Cleared Jan 22, 2021
Nerivio, FGD000075-4.7
K203181 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 88d
Cleared Jan 21, 2021
DIR 800
K202391 · IZI
Aesculap, Inc.
Neurology · 153d
Cleared Jan 14, 2021
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment...
K202694 · GZT
Vycor Medical, Inc.
Neurology · 120d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Medtronic Navigation, Inc.
Neurology · 30d
Cleared Jan 02, 2021
Sparrow Therapy System
K201873 · PZR
Spark Biomedical, Inc.
Neurology · 179d
Cleared Dec 31, 2020
Sim&Size
K202322 · PZO
Sim&Cure
Neurology · 136d
Cleared Dec 30, 2020
NeuroAmp II, NeuroAmp II.5s
K193159 · GWQ
Corscience GmbH & Co. KG
Neurology · 411d
Cleared Dec 29, 2020
First Relief v1
K202940 · QHH
Dyansys, Inc.
Neurology · 90d
Cleared Dec 29, 2020
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
K203219 · POL
Stryker Neurovascular
Neurology · 57d
Cleared Dec 27, 2020
8-CH Electroencephalography Amplifier
K201747 · GWL
Hipposcreen Neurotech Corp.
Neurology · 184d
Cleared Dec 25, 2020
ImPACT Version 4
K202485 · POM
Impact Applications, Inc.
Neurology · 116d
Cleared Dec 23, 2020
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE...
K200697 · GXH
AtriCure, Inc.
Neurology · 281d
Cleared Dec 23, 2020
Scrambler Therapy Technology (Model ST-5A)
K201458 · GZJ
Delta International Services &...
Neurology · 205d
Cleared Dec 22, 2020
EZTrack
K201910 · OLX
Neurologic, LLC
Neurology · 166d
Cleared Dec 22, 2020
actiTENS
K202159 · GZJ
Sublimed
Neurology · 141d
Cleared Dec 22, 2020
Everyway Analog OTC TENS, model N103A/N302
K202849 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 85d
Cleared Dec 22, 2020
COOLIEF Cooled Radiofrequency Kit Advanced
K203066 · GXI
Avanos Medical, Inc.
Neurology · 74d
Cleared Dec 16, 2020
Longeviti ClearFit Cranial Implant
K203349 · GXN
Longeviti Neuro Solutions, LLC
Neurology · 33d