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
May 31, 2024
Deep TMS System
OBP
Transcranial Magnetic Stimulator
679d
Cleared
May 29, 2024
NET Recovery Corp/NET Device
PZR
Percutaneous Nerve Stimulator For Opioid Withdrawal
245d
Cleared
May 28, 2024
React 71 Catheter
DQY
Catheter, Percutaneous
29d
Cleared
May 24, 2024
Racz Neurostat RF Generator
GXD
Generator, Lesion, Radiofrequency
268d
Cleared
May 24, 2024
Apollo TMS Therapy System
OBP
Transcranial Magnetic Stimulator
268d
Cleared
May 16, 2024
Wedge XL Delivery Catheter
QJP
Catheter, Percutaneous, Neurovasculature
268d
Cleared
May 15, 2024
TRIUX™ neo (NM27000N )
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
149d
Cleared
May 13, 2024
BEAR 2 Body
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
290d
Cleared
May 09, 2024
CEREGLIDE 92 Catheter System
QJP
Catheter, Percutaneous, Neurovasculature
143d
Cleared
May 07, 2024
Medical HAL Lower Limb Type (HAL-ML)
PHL
Powered Exoskeleton
172d
Cleared
Apr 30, 2024
Flexset System
GWQ
Full-montage Standard Electroencephalograph
209d
Cleared
Apr 26, 2024
Bone Anchor (NGS-BA-01)
HAW
Neurological Stereotaxic Instrument
161d
Cleared
Apr 24, 2024
DORO LUCENT Skull Clamp (1101.001)
HBL
Holder, Head, Neurosurgical (skull Clamp)
82d
Cleared
Apr 23, 2024
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
NRY
Catheter, Thrombus Retriever
207d
Cleared
Apr 22, 2024
MamaLift Plus
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
517d
Cleared
Apr 19, 2024
Electrical Neuromuscular Stimulator, Cure Trio
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
207d
Cleared
Apr 19, 2024
SafeOp 3: Neural Informatix Systeem
GWF
Stimulator, Electrical, Evoked Response
115d
Cleared
Apr 18, 2024
EMBOGUARD Balloon Guide Catheter
QJP
Catheter, Percutaneous, Neurovasculature
127d
Cleared
Apr 15, 2024
Glide (91000-GL-X)
GXY
Electrode, Cutaneous
14d
Cleared
Apr 04, 2024
VSP PEEK Cranial Implant
GWO
Plate, Cranioplasty, Preformed, Alterable
287d
Cleared
Apr 03, 2024
Oxevision Sleep Device
LEL
Device, Sleep Assessment
142d
Cleared
Mar 30, 2024
Rejoyn
SAP
Computerized Behavioral Therapy Device For Depressive Disorders.
338d
Cleared
Mar 28, 2024
CustomizedBone Service
GXN
Plate, Cranioplasty, Preformed, Non-alterable
28d
Cleared
Mar 27, 2024
Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
315d
Cleared
Mar 27, 2024
Modius Stress
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
243d
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