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
Sep 27, 2024
encevis (2.1)
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
169d
Cleared
Sep 27, 2024
Sourcerer
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
121d
Cleared
Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
HCG
Device, Neurovascular Embolization
28d
Cleared
Sep 26, 2024
Permatage Settable Bone Putty
GXP
Methyl Methacrylate For Cranioplasty
164d
Cleared
Sep 20, 2024
Traus SSG10 Surgical System
HBC
Motor, Drill, Electric
359d
Cleared
Sep 20, 2024
NeuroField Analysis Suite
OLU
Normalizing Quantitative Electroencephalograph Software
220d
Cleared
Sep 20, 2024
Millipede 088 Access Catheter
NRY
Catheter, Thrombus Retriever
29d
Cleared
Sep 16, 2024
Traus SSG30 Surgical System
HBC
Motor, Drill, Electric
362d
Cleared
Sep 09, 2024
TENS & EMS Stimulator (MHD-1083)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Sep 04, 2024
DreamClear
GWL
Amplifier, Physiological Signal
181d
Cleared
Sep 04, 2024
BE Plus PRO, Neurotravel LIGHT
GWL
Amplifier, Physiological Signal
30d
Cleared
Sep 04, 2024
SignalNED System (Model RE)
OMC
Reduced- Montage Standard Electroencephalograph
30d
Cleared
Aug 30, 2024
Unipro (K-UNIPRO-US)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
382d
Cleared
Aug 30, 2024
Daylight
SCP
Computerized Behavioral Therapy Device For Anxiety Disorders
267d
Cleared
Aug 30, 2024
Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire)
OBP
Transcranial Magnetic Stimulator
93d
Cleared
Aug 30, 2024
Talee, Talee PostOp
MVA
Orthosis, Cranial
58d
Cleared
Aug 29, 2024
Target Detachable Coils
HCG
Device, Neurovascular Embolization
29d
Cleared
Aug 29, 2024
Grass® MR Conditional/CT Cup Electrodes
GXY
Electrode, Cutaneous
22d
Cleared
Aug 28, 2024
BT-1000
QGL
Transcutaneous Nerve Stimulator For Adhd
341d
Cleared
Aug 23, 2024
Nalu Neurostimulation System for Spinal Cord Stimulation
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
268d
Cleared
Aug 23, 2024
VEEGix EEG System
OLT
Non-normalizing Quantitative Electroencephalograph Software
175d
Cleared
Aug 21, 2024
Nalu Neurostimulation System for Peripheral Nerve Stimulation
GZF
Stimulator, Peripheral Nerve, Implanted (pain Relief)
376d
Cleared
Aug 21, 2024
cCeLL - In vivo
GWG
Endoscope, Neurological
324d
Cleared
Aug 20, 2024
Borvo EVAC System (Ergo)
JXG
Shunt, Central Nervous System And Components
89d
Cleared
Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
GXD
Generator, Lesion, Radiofrequency
30d
Looking for a specific neurology device? Search by device name, K-number or manufacturer.
Search all Neurology 510(k) devices