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
265–288 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
K251247 · GXD
Boston Scientific Neuromodulation...
Neurology · 106d
Cleared Aug 06, 2025
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology...
K243552 · JXG
Integra Lifesciences Production...
Neurology · 264d
Cleared Jul 31, 2025
Sleep Watch
K251574 · LEL
Ambulatory Monitoring, Inc.
Neurology · 70d
Cleared Jul 30, 2025
Micro Catheter
K243534 · KRA
Suzhou Zenith Vascular SciTech Limited
Neurology · 257d
Cleared Jul 30, 2025
T65 (9016E061-)
K252032 · OBP
Tonica Elektronik A/S
Neurology · 30d
Cleared Jul 25, 2025
Fusion Craniofacial Implant
K250334 · GWO
Kelyniam Global, Inc.
Neurology · 170d
Cleared Jul 22, 2025
VersaCoat Nerve Protector (VTP-44G2)
K251505 · JXI
Alafair Biosciences
Neurology · 67d
Cleared Jul 18, 2025
MF SC GEN2 Facial Toning System
K252218 · NFO
Micro Current Technology, Inc.
Neurology · 3d
Cleared Jul 17, 2025
0.014” Willow Guidewire
K243756 · MOF
Arbor Endovascular, LLC
Neurology · 223d
Cleared Jul 17, 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · JXI
Alafair Biosciences
Neurology · 92d
Cleared Jul 16, 2025
StimTrial Neuromodulation System
K243782 · GZF
Bioventus, LLC
Neurology · 219d
Cleared Jul 12, 2025
NightWatch+ US
K243199 · POS
Livassured BV
Neurology · 284d
Cleared Jul 11, 2025
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
K251472 · HBW
Inion OY
Neurology · 59d
Cleared Jul 10, 2025
Microcurrent Facial Device (CEC101, EE0101, EEI101)
K244004 · NFO
Shenzhen Dachi Communication Co., Ltd.
Neurology · 196d
Cleared Jul 09, 2025
EZ-FIDUCIALS
K250505 · HAW
Phasor Health, LLC
Neurology · 138d
Cleared Jul 03, 2025
Onera STS 2 (ONERA STS 2)
K243220 · MNR
Onera B.V.
Neurology · 269d
Cleared Jul 03, 2025
TalisMann Neuromodulation System
K243678 · GZF
Bioventus, LLC
Neurology · 218d
Cleared Jul 02, 2025
Pure Impact
K251746 · NGX
Sofwave Medical, Ltd.
Neurology · 26d
Cleared CT Jul 01, 2025
Felix NeuroAI System
K250096 · QBC
Fasikl Incorporated
Neurology · 168d
Cleared Jun 27, 2025
Affirm 800
K243077 · IZI
Digital Surgery Systems, Inc. (D.B.A...
Neurology · 270d
Cleared Jun 27, 2025
Ampa One System (AMPA-001)
K251210 · OBP
Neuromodulatory Devices & Applications
Neurology · 70d
Cleared Jun 26, 2025
Neuralytix iD3 System (NTX-9001)
K243636 · PDQ
Neuralytix, LLC
Neurology · 213d
Cleared Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar...
K242974 · JXG
Sophysa
Neurology · 267d
Cleared Jun 20, 2025
Branchor X Balloon Guide Catheter
K251240 · QJP
Asahi Intecc Co., Ltd.
Neurology · 59d