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
841–864 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Dec 21, 2021
Meticuly Patient-Specific Titanium Mesh Implant
K210099 · GXN
Meticuly Co., Ltd.
Neurology · 341d
Cleared Dec 20, 2021
First Relief
K212859 · NHI
Dyansys, Inc.
Neurology · 103d
Cleared Dec 20, 2021
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K213031 · NCX
Zoll Circulation, Inc.
Neurology · 90d
Cleared Dec 17, 2021
EMBOGUARD Balloon Guide Catheter
K212340 · QJP
Neuravi Limited
Neurology · 142d
Cleared Dec 16, 2021
MIVI Q Distal Access Catheter
K212402 · QJP
Mivi Neuroscience, Inc.
Neurology · 136d
Cleared Dec 15, 2021
Transcutaneous Electrical Nerve Stimulator
K210223 · NUH
Top-Rank Health Care Co., Ltd.
Neurology · 321d
Cleared Dec 13, 2021
Aesculap Slim Clip Applier
K211572 · HCI
Aesculap, Inc.
Neurology · 206d
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