FDA 510(k) Neurology Devices
About Neurology Devices
FDA 510(k) neurology devices cover diagnostic and therapeutic equipment for the nervous system. The FDA review panel code is NE.
Common categories include:
- EEG and neurophysiology systems - electroencephalographs, EMG, nerve conduction
- Neurostimulators - transcranial magnetic stimulation (TMS), vagus nerve stimulation
- Surgical navigation systems - image-guided neurosurgery platforms
- Intracranial pressure monitors - ICP sensors and drainage systems
- Neuroendoscopes - rigid and flexible scopes for minimally invasive neurosurgery
6214
Total
6160
Cleared
148d
Avg days
1976
Since
553 Neurology devices
Cleared
Apr 24, 2025
Freespira Breathing System
SEN
Biofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety
573d
Cleared
Apr 21, 2025
CHIKAI Nexus 014
MOF
Guide, Wire, Catheter, Neurovasculature
172d
Cleared
Apr 18, 2025
SofWave System
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
87d
Cleared
Apr 17, 2025
Ultimate rTMS
OBP
Transcranial Magnetic Stimulator
160d
Cleared
Apr 17, 2025
Ultimate rTMS for OCD (M-series)
QCI
Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
160d
Not Cleared
Apr 17, 2025
Minder System
SEM
Sub-scalp Implanted Electroencephalogram System For Remote Patient Monitoring
181d
Cleared
Apr 16, 2025
DCM (PW-DCM)
LEL
Device, Sleep Assessment
155d
Cleared
Apr 14, 2025
Atlas Stim Headbox (NK) (31-0601-0077)
GYC
Electrode, Cortical
90d
Cleared
Apr 11, 2025
Canvas Dx
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
144d
Not Cleared
Apr 11, 2025
CT-132
SEE
Computerized Behavioral Therapy Device For Migraine
150d
Cleared
Apr 10, 2025
cryoICE cryoXT cryoablation probe (cryoXT)
GXH
Device, Surgical, Cryogenic
59d
Cleared
Apr 10, 2025
NEAT 001
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
90d
Cleared
Apr 09, 2025
AURORA® Surgiscope® System (ASX15/60)
GWG
Endoscope, Neurological
28d
Cleared
Apr 09, 2025
autoSCORE (V 2.0.0)
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
126d
Cleared
Apr 09, 2025
Patch-TEA (Model TRI-21)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
138d
Cleared
Apr 09, 2025
Ceribell Seizure Detection Software
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
310d
Cleared
Apr 08, 2025
Jmoon Conductive Gel
GYB
Media, Electroconductive
124d
Cleared
Apr 07, 2025
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Apr 04, 2025
EyeBOX EBX-4.1
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
259d
Cleared
Apr 02, 2025
Remplir (ON-152, 15 x 20 mm)
JXI
Cuff, Nerve
105d
Cleared
Apr 02, 2025
Progenix Select Stim
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
226d
Cleared
Apr 02, 2025
Nerve Wrap (07-DW-001-TAB)
JXI
Cuff, Nerve
257d
Cleared
Apr 01, 2025
Aristotle 14 Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
102d
Cleared
Apr 01, 2025
Préime DermaFacial (MicroT)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
186d
Cleared
Mar 30, 2025
Neuro Omega System
GZL
Electrode, Depth
30d
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