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
1345–1368 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 13, 2019
AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
K183464 · NRY
Stryker
Neurology · 89d
Cleared Mar 12, 2019
AirRay Subdural Cortical Electrodes
K183437 · GYC
Cortec GmbH
Neurology · 90d
Cleared Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
K183177 · GXI
Boston Scientific Corporation
Neurology · 112d
Cleared Mar 08, 2019
Brainsway Deep TMS System
K183303 · QCI
Brainsway , Ltd.
Neurology · 101d
Cleared Mar 08, 2019
Rulo Radiofrequency Lesion Probe
K190256 · GXI
Epimed International, Inc.
Neurology · 29d
Cleared Mar 07, 2019
Cervella
K182311 · QJQ
Innovative Neurological Devices, LLC
Neurology · 195d
Cleared CT Mar 06, 2019
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization...
K181807 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 243d
Cleared Mar 06, 2019
Visualase Thermal Therapy System
K181859 · LLZ
Medtronic Navigation, Inc.
Neurology · 237d
Cleared Feb 27, 2019
PAT (Pain Alleviation Technologies)
K182267 · NUH
Marchan Medical, LLC
Neurology · 190d
Cleared Feb 26, 2019
Tyece OTC EMS System
K183454 · NGX
Tyece , Ltd.
Neurology · 75d
Cleared Feb 25, 2019
SpringTMS
K182976 · OKP
Eneura, Inc.
Neurology · 122d
Cleared Feb 22, 2019
The EPAD 2 System
K182542 · GWF
Safeop Surgical, Inc.
Neurology · 158d
Cleared Feb 19, 2019
BrainScope TBI (Model: Ahead 400)
K183241 · PIW
Brainscope Company, Inc.
Neurology · 90d
Cleared Feb 17, 2019
TMS-Cobot TS MV
K182768 · QFF
Axilum Robotics
Neurology · 142d
Cleared Feb 07, 2019
ROSA ONE Brain Application
K182417 · HAW
Medtech S.A
Neurology · 155d
Cleared Jan 29, 2019
Solitaire 4 Revascularization Device
K183022 · POL
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 89d
Cleared Jan 29, 2019
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K183070 · MOF
Asahi Intecc Co., Ltd.
Neurology · 85d
Cleared Jan 20, 2019
Codman Disposable Perforators
K183581 · HBF
Integra Lifesciences Corp.
Neurology · 30d
Cleared Jan 19, 2019
ELAN 4 Tools
K182527 · HBE
Aesculap, Inc.
Neurology · 127d
Cleared Jan 18, 2019
Aurora Surgiscope System
K182211 · GWG
Rebound Therapeutics Corporation
Neurology · 156d
Cleared Jan 17, 2019
DL Self-adhesive Electrode
K182111 · GXY
Shaoxing DL Healthcare Co., Ltd.
Neurology · 164d
Cleared Jan 17, 2019
Esprit Nova
K182227 · OLZ
Neurozone Msh Incorporated
Neurology · 154d
Cleared Jan 11, 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · GWM
Integra Lifesciences Corp.
Neurology · 32d
Cleared Jan 10, 2019
Maxpower Relief
K182120 · NUH
Omron Healthcare, Inc.
Neurology · 157d