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
361–384 of 6,334
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 12, 2025
Wireless TENS & EMS Unit
K243763 · NGX
Changsha Anxiang Medical Technology...
Neurology · 96d
Cleared Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · HBE
Stryker Instruments
Neurology · 29d
Cleared Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
K243676 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Mar 07, 2025
EpiWatch Monitoring System
K243515 · POS
Epiwatch, Inc.
Neurology · 114d
Cleared Mar 06, 2025
PureLift GLOW
K243587 · NFO
Xtreem Pulse, LLC
Neurology · 106d
Cleared Feb 28, 2025
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
K242676 · POL
Phenox Limited
Neurology · 175d
Cleared Feb 26, 2025
Millipede 070 Aspiration Catheter
K250012 · NRY
Perfuze, Ltd.
Neurology · 55d
Cleared Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
K243287 · NRY
Alembic, LLC
Neurology · 129d
Cleared Feb 20, 2025
Falcon HST
K242447 · OLV
Compumedics Limited
Neurology · 188d
Cleared Feb 18, 2025
AXS Lift Intracranial Base Catheter
K243593 · QJP
Stryker Neurovascular
Neurology · 90d
Cleared Feb 15, 2025
Sway System Sports Plus
K241737 · POM
Sway Medical, Inc.
Neurology · 243d
Cleared Feb 13, 2025
Penumbra System (Reperfusion Catheter RED 72)
K242104 · NRY
Penumbra, Inc.
Neurology · 210d
Cleared Feb 13, 2025
Ampa One System (AMPA-001)
K243319 · OBP
Neuromodulatory Devices & Applications
Neurology · 113d
Cleared Feb 10, 2025
Myolight Microcurrent Handpiece
K243063 · NFO
Raja Trading Company, Inc.
Neurology · 136d
Cleared Feb 06, 2025
Delphi MCS Electrode Cap
K243243 · GXY
Quantalx Neuroscience, Ltd.
Neurology · 118d
Cleared Feb 05, 2025
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · HAW
Claronav
Neurology · 271d
Cleared Feb 03, 2025
JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK,...
K243393 · NFO
Shenzhen Ulike Smart Electronics Co.,...
Neurology · 95d
Cleared Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · HAW
Brainlab AG
Neurology · 60d
Cleared Jan 24, 2025
ClearPoint System (Software Version 3.0)
K243657 · HAW
ClearPoint Neuro, Inc.
Neurology · 58d
Cleared Jan 23, 2025
RF Cannula
K241367 · GXI
Shanghai Samedical & Plastic...
Neurology · 254d
Cleared Jan 22, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
K242446 · OMB
Persyst Development Corporation
Neurology · 159d
Cleared Jan 22, 2025
Nicolet EDX
K243982 · GWF
Natus Neurology Incorporated
Neurology · 30d
Cleared Jan 17, 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · HAW
KOH YOUNG TECHNOLOGY, Inc.
Neurology · 252d
Cleared Jan 17, 2025
VersaD Delivery Catheter
K242051 · QJP
Unity Medical, Inc.
Neurology · 189d