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
554 Neurology devices
Cleared
Dec 30, 2024
Next Generation Access Platform
QJP
Catheter, Percutaneous, Neurovasculature
143d
Cleared
Dec 27, 2024
FLASH EVD System (10-0002)
HAW
Neurological Stereotaxic Instrument
128d
Cleared
Dec 26, 2024
iovera° System
GXH
Device, Surgical, Cryogenic
29d
Cleared
Dec 23, 2024
Noxturnal Web
OLV
Standard Polysomnograph With Electroencephalograph
230d
Cleared
Dec 19, 2024
Echo Intracranial Base Catheter
QJP
Catheter, Percutaneous, Neurovasculature
195d
Cleared
Dec 19, 2024
Broadway 8 Catheter
QJP
Catheter, Percutaneous, Neurovasculature
182d
Cleared
Dec 19, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
44d
Not Cleared
Dec 19, 2024
ARC-EX System
SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
266d
Cleared
Dec 17, 2024
POCKET TENS (EP-300)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Dec 16, 2024
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
JXG
Shunt, Central Nervous System And Components
160d
Cleared
Dec 14, 2024
Sim&Size
PZO
Software For Visualization Of Vascular Anatomy And Intravascular Devices
148d
Cleared
Dec 13, 2024
CAIs Sensor (CAIs-001)
GXY
Electrode, Cutaneous
231d
Cleared
Dec 13, 2024
BTL-785BNF-E
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
109d
Cleared
Dec 12, 2024
Infrascanner Model 2500 (Model 2500)
OPT
Infrared Hematoma Detector
211d
Cleared
Dec 12, 2024
NExT Station
GWL
Amplifier, Physiological Signal
84d
Cleared
Dec 12, 2024
Natus Ultrapro S100 (982A0594)
GWF
Stimulator, Electrical, Evoked Response
30d
Cleared
Dec 11, 2024
Disposable Subdermal Needle Electrode, Corkscrew
GXZ
Electrode, Needle
238d
Cleared
Dec 11, 2024
Access25™ Delivery Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
153d
Cleared
Dec 08, 2024
HomeSleepTest (HST, HST REM+)
OLV
Standard Polysomnograph With Electroencephalograph
269d
Cleared
Dec 06, 2024
87 NeuGlide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
241d
Cleared
Dec 04, 2024
Socrates 38 Catheter
QJP
Catheter, Percutaneous, Neurovasculature
124d
Cleared
Nov 26, 2024
NeuroMatch
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
195d
Cleared
Nov 25, 2024
WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)
GXY
Electrode, Cutaneous
269d
Cleared
Nov 22, 2024
Neuvotion NeuStim NN-01
GZI
Stimulator, Neuromuscular, External Functional
261d
Cleared
Nov 22, 2024
Dreem 3S
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
128d
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