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
1105–1128 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Not Cleared Jun 15, 2020
EndeavorRx
DEN200026 · QFT
Akili Interactive Labs, Inc.
Neurology · 60d
Cleared Jun 12, 2020
Electrical Stimulator System
K192201 · NUH
Gymmax Technology Shenzen Co., Ltd.
Neurology · 304d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271 · DQY
Penumbra, Inc.
Neurology · 30d
Cleared Jun 03, 2020
Flap Fixator, Burr Hole Cover
K192310 · GXR
Ossaware Biotech Co., Ltd.
Neurology · 282d
Cleared Jun 03, 2020
StealthStation Cranial Software v1.3.0
K201175 · HAW
Medtronic Navigation, Inc.
Neurology · 33d
Cleared Jun 02, 2020
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile...
K193438 · HBL
Pro-Med Instruments GmbH
Neurology · 174d
Cleared Jun 01, 2020
BRAINSTREAM Disposable Deep Cup EEG Electrodes
K200540 · GXY
Conmed Corporation
Neurology · 90d
Cleared May 29, 2020
ROSA ONE Brain application
K200511 · HAW
Medtech S.A
Neurology · 88d
Cleared May 27, 2020
Guardian Needle Electrode
K200984 · GXZ
Rhythmlink International, LLC
Neurology · 43d
Cleared May 26, 2020
ReWalk P6.0
K200032 · PHL
Re Walk Robotics , Ltd.
Neurology · 140d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level,...
K201118 · GWM
Medtronic, Inc.
Neurology · 29d
Cleared May 18, 2020
Natus NeuroWorks
K200878 · OMB
Natus Medical Incorporated Dba...
Neurology · 46d
Cleared May 13, 2020
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
K190118 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 475d
Cleared May 08, 2020
Ventricular Catheter
K200950 · JXG
Aesculap, Inc.
Neurology · 29d
Cleared May 04, 2020
LIVIA
K183110 · NUH
Lifecare , Ltd.
Neurology · 543d
Cleared May 02, 2020
RIST Radial Access Catheter
K200417 · QJP
Rist Neurovascular, Inc.
Neurology · 72d
Cleared May 02, 2020
BOSS Balloon Guide Catheter
K200910 · QJP
Marblehead Medical
Neurology · 26d
Cleared Apr 29, 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807 · JXG
Irras USA, Inc.
Neurology · 33d
Cleared Apr 26, 2020
MECTA Sigma
K192834 · QGH
Mecta Corporation
Neurology · 207d
Cleared Apr 25, 2020
i-ED COIL
K192068 · HCG
Kaneka Pharma America, LLC
Neurology · 268d
Cleared Apr 24, 2020
Maxxi Position Sensor
K191492 · GWQ
Neurovirtual USA, Inc.
Neurology · 324d
Cleared Apr 24, 2020
GSI Audera Pro
K193033 · GWJ
Grason Stadler
Neurology · 176d
Cleared Apr 23, 2020
Nurochek System
K200705 · GWE
Cryptych Pty, Ltd.
Neurology · 36d
Cleared Apr 21, 2020
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
K200162 · GXY
Wuhan Greentek Pty , Ltd.
Neurology · 90d