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
Oct 27, 2025
TECHFIT Patient-Specific Cranial System
GWO
Plate, Cranioplasty, Preformed, Alterable
269d
Cleared
Oct 24, 2025
VersaD Delivery Catheter
QJP
Catheter, Percutaneous, Neurovasculature
175d
Cleared
Oct 24, 2025
Atalante X
PHL
Powered Exoskeleton
212d
Cleared
Oct 22, 2025
Carrier XL Delivery Catheter
QJP
Catheter, Percutaneous, Neurovasculature
69d
Cleared
Oct 21, 2025
NeuroAlign software
HAW
Neurological Stereotaxic Instrument
846d
Cleared
Oct 17, 2025
InZone IST Detachment System
HCG
Device, Neurovascular Embolization
123d
Cleared
Oct 17, 2025
JOVS Electric Stimulation Beauty Device (JE2)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
263d
Cleared
Oct 12, 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
192d
Cleared
Oct 10, 2025
Zeta Navigation System (ZNS131-US)
SGE
Extracranial Positional System For A Transcranial Magnetic Stimulation System
109d
Cleared
Oct 09, 2025
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
57d
Cleared
Oct 09, 2025
EEG-1260A Neurofax System (EEG-1260A)
OLT
Non-normalizing Quantitative Electroencephalograph Software
161d
Cleared
Oct 06, 2025
Tigertriever 17 Ultra Revascularization Device
NRY
Catheter, Thrombus Retriever
132d
Not Cleared
Oct 06, 2025
PainChek (PainChek Adult)
SGB
Pain Assessment Software In Non-communicative Adults
299d
Cleared
Sep 29, 2025
allay Nerve Cap (TL5515-1)
SBG
In Situ Polymerizing Peripheral Nerve Cap
90d
Cleared
Sep 26, 2025
Optima Coil System (Optima Packing Coil System)
HCG
Device, Neurovascular Embolization
30d
Cleared
Sep 25, 2025
EMBOTRAP III Revascularization Device
NRY
Catheter, Thrombus Retriever
106d
Cleared
Sep 19, 2025
UniBur
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
28d
Cleared
Sep 18, 2025
Sunny Plus (Sunny)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
112d
Cleared
Sep 14, 2025
CloudTMS Edge
OBP
Transcranial Magnetic Stimulator
192d
Cleared
Sep 13, 2025
BrainsWay Deep TMS System
OBP
Transcranial Magnetic Stimulator
127d
Cleared
Sep 12, 2025
Legend X Platform
GEI
Electrosurgical, Cutting & Coagulation & Accessories
29d
Cleared
Sep 08, 2025
Coaptium Connect with Tissium Light
SFD
In Situ Polymerizing Peripheral Nerve Repair Device
75d
Cleared
Sep 08, 2025
DUO Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
161d
Cleared
Sep 05, 2025
SOLOPASS 2.0 System
HAW
Neurological Stereotaxic Instrument
129d
Cleared
Sep 04, 2025
Mobile Laser Unit (1001-N2)
ONO
Neurosurgical Laser With Mr Thermography
129d
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