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
549 Neurology devices
Cleared
Nov 26, 2025
0.014” Willow Guidewire
MOF
Guide, Wire, Catheter, Neurovasculature
61d
Cleared
Nov 25, 2025
NX01 (NX01)
OMC
Reduced- Montage Standard Electroencephalograph
188d
Cleared
Nov 24, 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Nov 21, 2025
LEGACY
HBG
Drills, Burrs, Trephines & Accessories (manual)
86d
Cleared
Nov 21, 2025
Ceribell Infant Seizure Detection Software
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
143d
Cleared
Nov 21, 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
157d
Cleared
Nov 21, 2025
Nelli (Version 7.11)
POS
Physiological Signal Based Seizure Monitoring System
189d
Cleared
Nov 18, 2025
Collagen Dura Regeneration Membrane - Repair
GXQ
Dura Substitute
215d
Cleared
Nov 17, 2025
DeepRESP
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
115d
Cleared
Nov 14, 2025
ARC-EX System
SDO
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
154d
Not Cleared
Nov 14, 2025
Neurolyser XR (NXR100)
SGN
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
203d
Cleared
Nov 12, 2025
Synthes Patient Specific Implants
GXN
Plate, Cranioplasty, Preformed, Non-alterable
345d
Cleared
Nov 10, 2025
KLS Martin Cranial Implants - MR Conditional
GXN
Plate, Cranioplasty, Preformed, Non-alterable
88d
Cleared
Nov 10, 2025
NeVasc Aspiration System
NRY
Catheter, Thrombus Retriever
223d
Cleared
Nov 07, 2025
BrainsWay Deep TMS System
OBP
Transcranial Magnetic Stimulator
186d
Cleared
Nov 07, 2025
Triathlon Pro
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
403d
Cleared
Nov 06, 2025
Hubly Drill (H100)
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
234d
Cleared
Nov 06, 2025
mb-FIX Cranial Stabilization Systems
HBL
Holder, Head, Neurosurgical (skull Clamp)
265d
Cleared
Nov 05, 2025
EVAC-MRI
JXG
Shunt, Central Nervous System And Components
86d
Cleared
Nov 05, 2025
Depth Electrode (RSDE-08)
GZL
Electrode, Depth
268d
Cleared
Oct 31, 2025
Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
113d
Cleared
Oct 31, 2025
GREEN
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
122d
Cleared
Oct 31, 2025
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
GXY
Electrode, Cutaneous
182d
Cleared
Oct 30, 2025
Zoom System (Zoom 4S Catheter)
NRY
Catheter, Thrombus Retriever
122d
Cleared
Oct 29, 2025
Medi Lift Essential Eye Mask
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
243d
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