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
1153–1176 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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 CT 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
Cleared Apr 18, 2020
Route 92 Medical 088 Access System, 110 cm
K200121 · QJP
Route 92 Medical, Inc.
Neurology · 88d
Cleared Apr 16, 2020
Traxcess 14 SELECT Guidewire
K200547 · MOF
MicroVention, Inc.
Neurology · 44d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Apr 06, 2020
Neural Navigator
K191422 · HAW
Soterix Medical, Inc.
Neurology · 313d
Cleared Apr 06, 2020
Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access...
K192558 · DQY
Mivi Neurovascular
Neurology · 202d