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
913–936 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 13, 2021
Heat StimPlus
K212918 · NUH
Famidoc Technology Co., Ltd.
Neurology · 90d
Cleared Dec 10, 2021
Branchor Balloon Guide Catheter
K203723 · QJP
Asahi Intecc Co., Ltd.
Neurology · 354d
Cleared Dec 10, 2021
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...
K213543 · OBP
Neuronetics, Inc.
Neurology · 32d
Cleared Dec 05, 2021
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant...
K211561 · MUD
Covidien, LLC
Neurology · 199d
Cleared Dec 03, 2021
Molecular Flow Simulations
K201435 · HAW
Therataxis, LLC
Neurology · 550d
Cleared Dec 02, 2021
AURORA Evacuator +Coag
K203745 · GEI
Rebound Therapeutics
Neurology · 345d
Cleared Dec 02, 2021
Encevis
K211452 · OMB
Austrian Institute of Technology GmbH
Neurology · 206d
Cleared Dec 01, 2021
AC Cream - Conductive paste
K212326 · GYB
Spes Medica Srl
Neurology · 128d
Cleared Nov 26, 2021
ALTMS Magnetic Stimulation Therapy System
K202537 · OBP
Remed Co., Ltd.
Neurology · 451d
Cleared Nov 26, 2021
Trevo Trak 21 Microcatheter
K211594 · QJP
Stryker Neurovascular
Neurology · 186d
Cleared Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm,...
K213454 · HBE
Medtronic Powered Surgical Solutions
Neurology · 28d
Cleared Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 63d
Cleared Nov 22, 2021
Spartan MC 0165
K213451 · QJP
Spartan Micro
Neurology · 27d
Cleared Nov 18, 2021
DIXI Medical Microdeep Micro-Macro Depth Electrodes
K202087 · GZL
Dixi Medical
Neurology · 478d
Cleared Nov 16, 2021
Esperance Aspiration Catheter System
K211697 · NRY
Wallaby Medical
Neurology · 166d
Cleared Nov 16, 2021
InZone Detachment System
K212455 · HCG
Stryker Neurovascular
Neurology · 103d
Cleared Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
K210989 · HAW
Brainlab AG
Neurology · 224d
Cleared Nov 09, 2021
Comby EEG Caps
K211315 · GXY
Pamel D.O.O
Neurology · 193d
Cleared Nov 08, 2021
GT5 conductive & abrasive gel
K212787 · GYB
Wuhan Greentek Pty , Ltd.
Neurology · 68d
Cleared Nov 05, 2021
MStim Drop Model: LGT-233
K202110 · GZI
Guangzhou Longest Science &...
Neurology · 463d
Cleared Nov 05, 2021
Microcurrent device (Model: HBR2-1)
K211055 · NFO
Shenzhen DJ Medical Equipment Co., Ltd.
Neurology · 210d
Cleared Nov 05, 2021
Drug Relief v1
K211971 · PZR
Dyansys, Inc.
Neurology · 134d
Cleared Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
K211544 · HAW
Brainlab AG
Neurology · 168d
Cleared Oct 22, 2021
P300 Attachment
K202120 · HBE
Nakanishi, Inc.
Neurology · 449d