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
Mar 30, 2025
Neuro Omega System
GZL
Electrode, Depth
30d
Cleared
Mar 28, 2025
Bullsai Confirm
QQC
Brain Stimulation Programming Planning Software.
135d
Cleared
Mar 28, 2025
Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)
BWK
Stimulator, Electro-acupuncture
88d
Cleared
Mar 27, 2025
Nurochek-Pro System
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
143d
Cleared
Mar 26, 2025
NM-01/CPT neurometer (NM-01/CPT)
JXE
Device, Nerve Conduction Velocity Measurement
427d
Cleared
Mar 26, 2025
EarliPoint System
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
98d
Cleared
Mar 21, 2025
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter
QJP
Catheter, Percutaneous, Neurovasculature
231d
Cleared
Mar 21, 2025
REMI Remote EEG Monitoring System
OMC
Reduced- Montage Standard Electroencephalograph
172d
Cleared
Mar 17, 2025
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
OBP
Transcranial Magnetic Stimulator
90d
Cleared
Mar 17, 2025
DOC Band 3D
OAN
Orthosis, Cranial, Laser Scan
76d
Cleared
Mar 14, 2025
DeepRESP
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
254d
Cleared
Mar 13, 2025
IceCap product line
GXY
Electrode, Cutaneous
94d
Cleared
Mar 13, 2025
Surgify Halo (54.085.SHD.H1)
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
30d
Cleared
Mar 12, 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
PHL
Powered Exoskeleton
261d
Cleared
Mar 12, 2025
Delphi Amplifier
GWL
Amplifier, Physiological Signal
97d
Cleared
Mar 12, 2025
Wireless TENS & EMS Unit
NGX
Stimulator, Muscle, Powered, For Muscle Conditioning
96d
Cleared
Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
29d
Cleared
Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
JXG
Shunt, Central Nervous System And Components
103d
Cleared
Mar 07, 2025
EpiWatch Monitoring System
POS
Physiological Signal Based Seizure Monitoring System
114d
Cleared
Mar 06, 2025
PureLift GLOW
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
106d
Cleared
Feb 28, 2025
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
POL
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
175d
Cleared
Feb 26, 2025
Millipede 070 Aspiration Catheter
NRY
Catheter, Thrombus Retriever
55d
Cleared
Feb 24, 2025
APRO 70 Swift Catheter and Alembic Aspiration Tubing
NRY
Catheter, Thrombus Retriever
129d
Cleared
Feb 20, 2025
Falcon HST
OLV
Standard Polysomnograph With Electroencephalograph
188d
Cleared
Feb 18, 2025
AXS Lift Intracranial Base Catheter
QJP
Catheter, Percutaneous, Neurovasculature
90d
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