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
601–624 of 6,269
Search insights Median review: 108d Cleared: 99% Top manufacturer: Medtronic Vascular Lead specialty: Neurology
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
Cleared May 22, 2023
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
K230443 · NUH
Jiangxi Royall Smart Technology Co.,...
Neurology · 90d
Cleared May 22, 2023
TracStar LDP Large Distal Platform
K231168 · QJP
Imperative Care, Inc.
Neurology · 27d
Cleared May 18, 2023
Spencer Probe Depth Electrodes
K223269 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 16, 2023
SAVI Dual (TM) Migraine Therapy
K230358 · OKP
Eneura, Inc.
Neurology · 95d
Cleared May 13, 2023
HEATING TENS/EMS, FT-810R
K223308 · NUH
Hivox Biotek, Inc.
Neurology · 197d
Cleared May 12, 2023
Waypoint GPS
K222106 · QWP
Waypoint Orthopedics, Inc.
Neurology · 298d
Cleared May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032,...
K222870 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 230d
Not Cleared May 09, 2023
Stanza
DEN220083 · QWI
Swing Therapeutics, Inc.
Neurology · 169d
Cleared May 08, 2023
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A,...
K223428 · NUH
Shenzhen Leqing Medical Instrument...
Neurology · 175d
Cleared May 04, 2023
Hubly Electric Drill (H100)
K230619 · HBE
Hubly, Inc.
Neurology · 59d
Cleared Apr 27, 2023
Cumulus Functional Neurophysiology Platform
K221963 · GWQ
Cumulus Neuroscience Limited
Neurology · 296d
Cleared Apr 26, 2023
TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
K230829 · NUH
Chongqing Rob Linka Science and...
Neurology · 30d
Cleared Apr 25, 2023
Wallaby 017 Micro Catheter
K223139 · KRA
Wallaby Medical
Neurology · 203d
Cleared Apr 24, 2023
SmartGUIDE deflectable hydrophilic guidewire
K222690 · MOF
Artiria Medical SA
Neurology · 230d
Cleared Apr 20, 2023
STARband 3D
K223238 · MVA
Orthomerica Products, Inc.
Neurology · 182d
Cleared Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements...
K223552 · HAW
Brainlab AG
Neurology · 145d