FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
673–696 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jan 19, 2023
Disposable Non-invasive EEG Sensor
K220448 · GXY
Shenzhen Med-Link Electronics Tech...
Neurology · 337d
Cleared Jan 19, 2023
Self-adhesive Electrode
K222252 · GXY
Shenzhen Roundwhale Technology Co. ,...
Neurology · 176d
Cleared Jan 13, 2023
MONTAGE Settable, Resorbable Bone Putty
K221933 · GXP
Orthocon, Inc.
Neurology · 196d
Cleared Jan 13, 2023
Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0,...
K222171 · OBP
Magstim Company, Ltd.
Neurology · 176d
Cleared Jan 13, 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K223746 · NCX
Zoll Circulation, Inc.
Neurology · 30d
Cleared Jan 12, 2023
Neuronaute with IceCap 2 & IceCap 2 Small
K223644 · GWQ
Bioserenity
Neurology · 37d
Cleared Jan 11, 2023
Alpha Control Liner System (ACLS)
K223738 · GXY
Coapt
Neurology · 28d
Cleared Jan 10, 2023
ISAAC Neurovascular Navigation Catheter
K222115 · DQY
MicroVention, Inc.
Neurology · 176d
Cleared Jan 03, 2023
EZ-STIK Electrodes
K223775 · GXY
South Dakota Partners
Neurology · 18d
Cleared Dec 30, 2022
Persyst 15 EEG Review and Analysis Software
K222002 · OMB
Persyst Development Corporation
Neurology · 176d
Cleared Dec 30, 2022
ControlSeal Electrode (ELSB)
K223605 · GXY
Coapt
Neurology · 28d
Cleared Dec 29, 2022
Atalante
K221859 · PHL
Wandercraft SAS
Neurology · 185d
Cleared Dec 29, 2022
Reflow System Mini and ReFlow Mini Flusher
K223603 · JXG
Anuncia Medical, Inc.
Neurology · 27d
Cleared Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · NUH
Andon Health Co, Ltd.
Neurology · 90d
Cleared Dec 20, 2022
Penumbra System (Reperfusion Catheter RED 43)
K222808 · NRY
Penumbra, Inc.
Neurology · 95d
Cleared Dec 14, 2022
Target Tetra Detachable Coils
K222533 · HCG
Stryker Neurovascular
Neurology · 114d
Cleared Dec 13, 2022
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx,...
K212071 · PCC
Cefaly Technology
Neurology · 529d
Cleared Dec 13, 2022
Conductive Gel
K222770 · GYB
Top-Rank Health Care Co., Ltd.
Neurology · 90d
Cleared Dec 09, 2022
CELLO II Balloon Guide Catheter
K223275 · QJP
Fuji Systems Corporation
Neurology · 46d
Cleared Dec 08, 2022
IRRAflow Active Fluid Exchange System (AFES)
K222471 · JXG
Irras USA
Neurology · 114d
Cleared Dec 06, 2022
iCE-SG2 Subcutaneous Electrode Kit
K222706 · GZL
Ice Neurosystems, Inc.
Neurology · 90d
Cleared Dec 06, 2022
Optima Coil System
K223386 · HCG
Balt USA, LLC
Neurology · 29d
Cleared Nov 30, 2022
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K220254 · OLT
Neurosoft , Ltd.
Neurology · 303d
Cleared Nov 28, 2022
pNOVUS 21 Microcatheter
K221279 · DQO
Phenox, Ltd.
Neurology · 209d