FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Neurology ×
6,269 results
289–312 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
Cleared Mar 17, 2025
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
K243869 · OBP
The Magstim Company Limited
Neurology · 90d
Cleared Mar 17, 2025
DOC Band 3D
K244056 · OAN
Cranial Technologies, Inc.
Neurology · 76d
Cleared Mar 14, 2025
DeepRESP
K241960 · OLZ
Nox Medical Ehf
Neurology · 254d
Cleared Mar 13, 2025
IceCap product line
K243788 · GXY
Bioserenity Medical Devices Group
Neurology · 94d
Cleared Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
K250380 · HBE
Surgify Medical OY
Neurology · 30d
Cleared Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822 · PHL
Rewalk Robotics Ltd. Dba Lifeward
Neurology · 261d
Cleared Mar 12, 2025
Delphi Amplifier
K243746 · GWL
Quantalx Neroscience
Neurology · 97d
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