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
1297–1320 of 6,291
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 15, 2019
HORIZON TMS Therapy System
K182853 · OBP
Magstim Company, Ltd.
Neurology · 156d
Cleared Mar 15, 2019
HIVOX OTC Electrical Stimulator
K190347 · NUH
Hivox Biotek, Inc.
Neurology · 29d
Cleared Mar 14, 2019
JKH Stimulator Plus
K182203 · NUH
Jkh USA, LLC
Neurology · 211d
Cleared Mar 14, 2019
L300 Go System
K190285 · GZI
Bioness, Inc.
Neurology · 31d
Cleared Mar 13, 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access...
K183463 · DQY
Stryker
Neurology · 89d
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 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