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
649–672 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Aug 09, 2023
Conductive Silicone Rubber Electrode
K231167 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 08, 2023
Ceribell Instant EEG Headband
K232052 · GXY
Ceribell, Inc.
Neurology · 29d
Cleared Aug 01, 2023
Aristotle 18 Guidewire
K231954 · MOF
Scientia Vascular, Inc.
Neurology · 29d
Cleared Jul 28, 2023
HJY VisualNext Endoscopic Vision System
K222735 · GWG
Hjy Smart Medical Device Co., Ltd.
Neurology · 322d
Cleared Jul 21, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software...
K223288 · HAW
Brainlab AG
Neurology · 269d
Cleared Jul 20, 2023
ROSA ONE Brain Application
K231103 · HAW
Medtech S.A.S
Neurology · 92d
Cleared Jul 19, 2023
Nu-beca Transcutaneous Electrical Nerve Stimulation
K223151 · NUH
Nu-Beca & Maxcellent Co.
Neurology · 287d
Cleared Jul 14, 2023
NaviNetics Reusable Stereotactic System (NN1000)
K231392 · HAW
Navinetics, Inc.
Neurology · 63d
Cleared Jun 30, 2023
REMI Remote EEG Monitoring System
K230933 · OMC
Epitel, Inc.
Neurology · 88d
Cleared Jun 29, 2023
SQ.line KERRISON
K223596 · HAE
Aesculap, Inc.
Neurology · 209d
Cleared Jun 29, 2023
EarliPoint
K230337 · QPF
Earlitec Diagnostics, Inc.
Neurology · 142d
Cleared Jun 29, 2023
Phantom XL Insulated Dilators
K231691 · GXZ
TeDan Surgical Innovations, Inc.
Neurology · 20d
Cleared Jun 28, 2023
Medi Lift PLUS
K220198 · NFO
Ya-Man, Ltd.
Neurology · 520d
Cleared Jun 23, 2023
ActiGraph LEAP activity monitor (ActiGraph LEAP)
K231532 · LEL
Actigraph, LLC
Neurology · 28d
Cleared Jun 22, 2023
SelectFlex Neurovascular Access System Family
K230322 · QJP
Q'Apel Medical, Inc.
Neurology · 136d
Cleared Jun 22, 2023
Talee, Talee PostOp
K230444 · MVA
Invent Medical USA, LLC
Neurology · 121d
Cleared Jun 21, 2023
PureLift Pro Edition
K230506 · NFO
Xtreem Pulse
Neurology · 117d
Cleared Jun 20, 2023
Sparrow Ascent
K230796 · PZR
Spark Biomedical, Inc.
Neurology · 90d
Cleared Jun 18, 2023
Sinobot X1
K220072 · HAW
Sinovation (Beijing) Medical...
Neurology · 524d
Cleared Jun 09, 2023
LVIS NeuroMatch
K222450 · OMB
LVIS Corporation
Neurology · 298d
Cleared Jun 08, 2023
OCD MT Cap (85-00397-000)
K231350 · QCI
Neuronetics
Neurology · 30d
Cleared Jun 01, 2023
SomniCheck
K223676 · GWL
Brainmatterz, LLC
Neurology · 175d
Cleared May 26, 2023
Cerebral Adaptive Index (CAI) Algorithm
K223651 · MUD
Edwards Lifesciences, LLC
Neurology · 171d
Cleared May 23, 2023
Ceribell Status Epilepticus Monitor
K223504 · OMB
Ceribell, Inc.
Neurology · 182d