FDA 510(k) Neurology Devices
FDA 510(k) Neurology Devices - Regulatory Overview
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
6291
Total
6236
Cleared
153d
Avg (2y)
1976
Since
4721 Neurology devices
Cleared
May 24, 2012
MAYFIELD SKULL CLAMP
HBL
Holder, Head, Neurosurgical (skull Clamp)
84d
Cleared
May 22, 2012
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
GWF
Stimulator, Electrical, Evoked Response
235d
Cleared
May 21, 2012
VISIONSEARCH 1
GWE
Stimulator, Photic, Evoked Response
129d
Cleared
May 17, 2012
LONG LIFE PADTM
GXY
Electrode, Cutaneous
86d
Cleared
May 02, 2012
JIAJIAN TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
267d
Cleared
May 02, 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
GWM
Device, Monitoring, Intracranial Pressure
196d
Cleared
Apr 25, 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
HCG
Device, Neurovascular Embolization
30d
Cleared
Apr 25, 2012
CAREFUSION NICOLET EDX
GWF
Stimulator, Electrical, Evoked Response
23d
Cleared
Apr 24, 2012
BRAIN BIOPSY NEEDLE
HAW
Neurological Stereotaxic Instrument
277d
Cleared
Apr 20, 2012
RAPID PROGRAMMER
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
136d
Cleared
Apr 20, 2012
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
GZI
Stimulator, Neuromuscular, External Functional
30d
Cleared
Apr 17, 2012
TARGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
27d
Cleared
Apr 11, 2012
NEURO CHECK DEVICE WITH IO-FLEX WIRE
HAE
Rongeur, Manual
133d
Cleared
Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
GWM
Device, Monitoring, Intracranial Pressure
75d
Cleared
Apr 04, 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
HCG
Device, Neurovascular Embolization
29d
Cleared
Apr 02, 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
HCG
Device, Neurovascular Embolization
60d
Cleared
Mar 30, 2012
ULTRA BEAUTY
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
227d
Cleared
Mar 27, 2012
SURGICASE GUIDE
HAW
Neurological Stereotaxic Instrument
298d
Cleared
Mar 23, 2012
GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
HAW
Neurological Stereotaxic Instrument
210d
Cleared
Mar 22, 2012
NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX
GWQ
Full-montage Standard Electroencephalograph
153d
Cleared
Mar 19, 2012
HIVOX BIOTEK INC.
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
214d
Cleared
Mar 16, 2012
NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P
OMA
Amplitude-integrated Electroencephalograph
28d
Cleared
Mar 15, 2012
CAREFUSION NICOLET EDX
GWF
Stimulator, Electrical, Evoked Response
241d
Cleared
Mar 09, 2012
HBIDB - HUMAN BRIAN INDEX SOFTWARE
OLU
Normalizing Quantitative Electroencephalograph Software
232d
Cleared
Mar 08, 2012
QUADRASPHERE 30 TO 60
HCG
Device, Neurovascular Embolization
72d
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