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
289–312 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
K251560 · QJP
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Jun 19, 2025
EpiMonitor
K250515 · POS
Empatica S.R.L.
Neurology · 118d
Not Cleared Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
DEN240066 · SFD
Tissium SA
Neurology · 208d
Cleared Jun 13, 2025
Prismira
K243729 · QFT
Lumos Labs, Inc.
Neurology · 192d
Cleared Jun 06, 2025
Geister K-Rex rongeurs
K242759 · HAE
Geister Medizin Technik GmbH
Neurology · 267d
Cleared Jun 05, 2025
Synchrony (20-3000)
K242704 · GZI
Synapse Biomedical, Inc.
Neurology · 269d
Cleared Jun 04, 2025
EVE Synergy (EVE-20M)
K241433 · IPF
Weero Co., Ltd.
Neurology · 379d
Cleared Jun 04, 2025
Surgify Halo (54.085.SHD.H1)
K251433 · HBE
Surgify Medical OY
Neurology · 27d
Cleared Jun 03, 2025
EVAC
K243205 · JXG
Phasor Health, LLC
Neurology · 245d
Cleared Jun 03, 2025
Raptor Aspiration Catheter
K243948 · NRY
Balt USA, LLC
Neurology · 162d
Cleared May 29, 2025
TENS AND EMS (TENS and Muscle Stimulator) ( Model...
K243856 · NUH
Shenzhen Astec Technology Co., Ltd.
Neurology · 164d
Cleared May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · ONO
Medtronic Navigation
Neurology · 115d
Cleared May 28, 2025
Zoom 7X Catheter
K243047 · NRY
Imperative Care, Inc.
Neurology · 243d
Cleared May 27, 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · GXI
Abbott Medical
Neurology · 250d
Cleared May 23, 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · HAW
Brain Navi Biotechnology Co., Ltd.
Neurology · 267d
Cleared May 23, 2025
NeuroMatch
K250239 · OLX
LVIS Corporation
Neurology · 116d
Cleared May 23, 2025
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
K250361 · NFO
Geske Beauty Tech GmbH
Neurology · 102d
Cleared May 23, 2025
93 NeuFlex Catheter
K251044 · QJP
Piraeus Medical
Neurology · 50d
Cleared May 21, 2025
HJY VisualNext 3D Endoscopic Vision System
K243429 · GWG
Hjy Smart Medical Device Co., Ltd.
Neurology · 197d
Cleared CT May 19, 2025
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
K243601 · NRY
Route 92 Medical, Inc.
Neurology · 179d
Cleared May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · GXI
Stryker Instruments
Neurology · 111d
Cleared CT May 14, 2025
Nerivio
K250405 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 90d
Cleared May 14, 2025
Helios Dura Regeneration Matrix
K250420 · GXQ
Helios Biomedical, Inc.
Neurology · 90d
Cleared May 11, 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
K250360 · NUH
Shenzhen Jiantuo Electronics Co., Ltd.
Neurology · 90d