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
552 Neurology devices
Cleared
Jul 22, 2025
VersaCoat Nerve Protector (VTP-44G2)
JXI
Cuff, Nerve
67d
Cleared
Jul 18, 2025
MF SC GEN2 Facial Toning System
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
3d
Cleared
Jul 17, 2025
VersaWrap Nerve Protector (VTP-2201)
JXI
Cuff, Nerve
92d
Cleared
Jul 17, 2025
0.014” Willow Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
223d
Cleared
Jul 16, 2025
StimTrial Neuromodulation System
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
219d
Cleared
Jul 12, 2025
NightWatch+ US
POS
Physiological Signal Based Seizure Monitoring System
284d
Cleared
Jul 11, 2025
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
HBW
Fastener, Plate, Cranioplasty
59d
Cleared
Jul 10, 2025
Microcurrent Facial Device (CEC101, EE0101, EEI101)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
196d
Cleared
Jul 09, 2025
EZ-FIDUCIALS
HAW
Neurological Stereotaxic Instrument
138d
Cleared
Jul 03, 2025
TalisMann Neuromodulation System
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
218d
Cleared
Jul 03, 2025
Onera STS 2 (ONERA STS 2)
MNR
Ventilatory Effort Recorder
269d
Cleared
Jul 02, 2025
Pure Impact
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
26d
Cleared
Jul 01, 2025
Felix NeuroAI System
QBC
External Upper Limb Tremor Stimulator
168d
Cleared
Jun 27, 2025
Ampa One System (AMPA-001)
OBP
Transcranial Magnetic Stimulator
70d
Cleared
Jun 27, 2025
Affirm 800
IZI
System, X-ray, Angiographic
270d
Cleared
Jun 26, 2025
Neuralytix iD3 System (NTX-9001)
PDQ
Neurosurgical Nerve Locator
213d
Cleared
Jun 20, 2025
FUBUKI XF-R Neurovascular Long Sheath
QJP
Catheter, Percutaneous, Neurovasculature
30d
Cleared
Jun 20, 2025
Branchor X Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
59d
Cleared
Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
JXG
Shunt, Central Nervous System And Components
267d
Cleared
Jun 19, 2025
EpiMonitor
POS
Physiological Signal Based Seizure Monitoring System
118d
Not Cleared
Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
SFD
In Situ Polymerizing Peripheral Nerve Repair Device
208d
Cleared
Jun 13, 2025
Prismira
QFT
Digital Therapeutic Software For Attention Deficit Hyperactivity Disorder
192d
Cleared
Jun 06, 2025
Geister K-Rex rongeurs
HAE
Rongeur, Manual
267d
Cleared
Jun 05, 2025
Synchrony (20-3000)
GZI
Stimulator, Neuromuscular, External Functional
269d
Cleared
Jun 04, 2025
Surgify Halo (54.085.SHD.H1)
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
27d
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