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
769–792 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822 · QJP
Penumbra, Inc.
Neurology · 134d
Cleared Nov 04, 2022
Self-adhesive Electrode
K222453 · GXY
Guangdong Comytens Medical Technology...
Neurology · 81d
Cleared Nov 04, 2022
Aquilo Sports CCT1500 System
K223164 · IRP
Aquilo Sports, LLC
Neurology · 28d
Cleared Oct 31, 2022
ORiGO System
K213697 · HBC
Bien-Air Surgery SA
Neurology · 342d
Cleared Oct 28, 2022
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
K214109 · GXN
Kontour(Xi?An) Medical Technology...
Neurology · 303d
Cleared Oct 26, 2022
Intracept Intraosseous Nerve Ablation System
K222281 · GXI
Relievant Medsystems, Inc.
Neurology · 89d
Cleared Oct 24, 2022
Neurosteer EEG Recorder
K221563 · OMC
Neurosteer, Inc.
Neurology · 146d
Cleared Oct 21, 2022
MCI-Neuro Fixation System
K212391 · GWO
Mci Medical Concept Innovation, Inc.
Neurology · 445d
Cleared Oct 21, 2022
PureLift Pro Plus
K221443 · NFO
Xtreem Pulse, LLC
Neurology · 156d
Cleared Oct 21, 2022
Electronic Pulse Stimulator
K221992 · NUH
Beijing Choice Electronic Technology...
Neurology · 107d
Cleared Oct 20, 2022
Evo® sEEG System
K222404 · GZL
Neuroone Medical Technologies Corp.
Neurology · 72d
Cleared Oct 14, 2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840 · JXG
Integra Lifesciences Production...
Neurology · 112d
Cleared Oct 11, 2022
Branchor Balloon Guide Catheter
K221951 · QJP
Asahi Intecc Co., Ltd.
Neurology · 98d
Cleared Oct 07, 2022
Rebellion
K221818 · HAE
Morpheus AG
Neurology · 106d
Cleared Oct 04, 2022
Route 92 Medical Full Length 070 Access System
K222743 · QJP
Route 92 Medical, Inc.
Neurology · 25d
Cleared Sep 29, 2022
ReFlow System Mini
K221918 · JXG
Anuncia Medical, Inc.
Neurology · 90d
Cleared Sep 23, 2022
Conductive Gel
K221724 · GYB
Tone-A-Matic International, Inc.
Neurology · 101d
Cleared Sep 23, 2022
ATEC IOM Accessory Instruments
K221821 · PDQ
Alphatec Spine, Inc.
Neurology · 92d
Cleared Sep 22, 2022
TRANBERG Thermoguide Therapy System
K214125 · ONO
Clinical Laserthermia Systems, AB
Neurology · 266d
Cleared Sep 22, 2022
Talee, Talee PostOP
K220681 · MVA
Invent Medical USA, LLC
Neurology · 198d
Cleared Sep 21, 2022
SomnoMetry
K221179 · OLZ
Neumetry Medical, Inc.
Neurology · 149d
Cleared Sep 20, 2022
Millipede 088 Access Catheter
K214048 · QJP
Perfuze, Ltd.
Neurology · 267d
Cleared Sep 16, 2022
Neuro Omega System, NeuroSmart System
K220553 · GZL
Alpha Omega Engineering , Ltd.
Neurology · 200d
Cleared Sep 16, 2022
ClearPoint System
K222519 · HAW
ClearPoint Neuro, Inc.
Neurology · 28d