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
745–768 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared Nov 22, 2022
WISE Cortical Strip (WCS)
K221123 · GYC
Wise S.R.L.
Neurology · 218d
Cleared CT Nov 22, 2022
Cala kIQ
K222237 · QBC
Cala Health, Inc.
Neurology · 119d
Cleared Nov 17, 2022
Parky App
K220820 · GYD
H2o Bilisim Yazilim
Neurology · 241d
Cleared Nov 15, 2022
Everyway Analog OTC TENS
K222488 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 90d
Cleared Nov 15, 2022
2.1 x 255mm Drill, 22mm Stop
K223199 · HBE
Biomet Microfixation
Neurology · 33d
Cleared Nov 11, 2022
Mapping Suction Probe
K212164 · ETN
Inomed Medizintechnik GmbH
Neurology · 487d
Cleared Nov 10, 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid,...
K211954 · GYC
Spes Medica Srl
Neurology · 505d