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
1–24 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Oct 30, 2026
PolySense
K260648 · GWL
Itamar Medical , Ltd.
Neurology · 245d
Cleared Oct 30, 2026
AesyBite Active
K260360 · HCC
Aesyra SA
Neurology · 268d
Cleared Oct 29, 2026
Minder® System
K262318 · SEM
Epi-Minder Pty, Ltd.
Neurology · 113d
Cleared Oct 29, 2026
SEEG-Tx® System (STX-SYS-001)
K260337 · GXD
Dixi Medical
Neurology · 269d
Cleared Oct 27, 2026
DORO® Headrest System for AVA
K262229 · HBL
Black Forest Medical GmbH
Neurology · 119d
Cleared Oct 26, 2026
NeuroAlign
K261997 · HAW
Medivis, Inc.
Neurology · 133d
Cleared Oct 26, 2026
FAQ™ (FAQ 401)
K261625 · NFO
Foreo, Inc.
Neurology · 164d
Cleared Oct 22, 2026
FAQ™ (FAQ 411)
K261565 · NFO
Foreo, Inc.
Neurology · 164d
Cleared Oct 22, 2026
Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
K260230 · BWK
Suzhou Medical Appliance Factory
Neurology · 269d
Cleared Oct 21, 2026
Toro 71 Aspiration Catheter
K262021 · NRY
Toro Neurovascular, Inc.
Neurology · 127d
Cleared Oct 20, 2026
Rongjian Self-adhesive Electrode
K262664 · GXY
Bozhou Rongjian Medical Appliance...
Neurology · 82d
Cleared Oct 18, 2026
Sway System (Sports Plus)
K262000 · POM
Sway Medical, Inc.
Neurology · 125d
Cleared Oct 16, 2026
Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
K263266 · NRY
Route 92 Medical, Inc.
Neurology · 28d
Cleared Oct 16, 2026
Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B,...
K261574 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 157d
Cleared Oct 16, 2026
cCeLL - In vivo
K260315 · GWG
VPIX Medical, Inc.
Neurology · 259d
Cleared Oct 15, 2026
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
K262214 · HAW
Guangzhou Aimooe Technology Co., Ltd.
Neurology · 107d
Cleared Oct 14, 2026
KARL STORZ Flexible Video Neuro-Endoscope
K260581 · GWG
Karl Storz SE & CO. KG
Neurology · 236d
Cleared Oct 09, 2026
Excelsior Reach Microcatheter
K261649 · QJP
Stryker Neurovascular
Neurology · 143d
Cleared Oct 09, 2026
Sleep Analysis Module
K261521 · OLZ
Neurotronics, LLC
Neurology · 155d
Cleared Oct 08, 2026
NEXT-Cue
K261805 · QWT
Neuroxt, Inc.
Neurology · 129d
Cleared Oct 06, 2026
APRO 88 Catheter
K261938 · QJP
Alembic, LLC
Neurology · 118d
Cleared Oct 02, 2026
Neurora
K260064 · QPF
Argus Cognitive, Inc.
Neurology · 266d
Cleared Oct 02, 2026
Ventricular Catheters, Thomale Catheter
K260044 · JXG
Aesculap, Inc.
Neurology · 268d
Cleared Oct 02, 2026
cCeLL405
K254030 · QFX
VPIX Medical, Inc.
Neurology · 290d