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
4737 Neurology devices
Cleared
Dec 05, 2005
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
73d
Cleared
Nov 30, 2005
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
GXI
Probe, Radiofrequency Lesion
28d
Cleared
Nov 23, 2005
GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955
HAW
Neurological Stereotaxic Instrument
148d
Cleared
Nov 23, 2005
ASSISTO ARM SYSTEMS
GWG
Endoscope, Neurological
54d
Cleared
Nov 22, 2005
RAPID PROGEAMMER 3.0
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
84d
Cleared
Nov 21, 2005
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
HBL
Holder, Head, Neurosurgical (skull Clamp)
24d
Cleared
Nov 18, 2005
VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS)
HAW
Neurological Stereotaxic Instrument
38d
Cleared
Nov 17, 2005
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
GWE
Stimulator, Photic, Evoked Response
344d
Cleared
Nov 04, 2005
SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
86d
Cleared
Nov 02, 2005
NAVIGATION SW HIP 3.1 ON CI
HAW
Neurological Stereotaxic Instrument
79d
Cleared
Nov 01, 2005
BIS EEG MONITOR, MODEL BISX4
OLW
Index-generating Electroencephalograph Software
8d
Cleared
Oct 28, 2005
XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059
IKN
Electromyograph, Diagnostic
85d
Cleared
Oct 27, 2005
VIRTUAL MEDICAL SYSTEMS MODEL VT3000
JXE
Device, Nerve Conduction Velocity Measurement
13d
Cleared
Oct 21, 2005
DEPUY CAS HIP INSTRUMENTATION
HAW
Neurological Stereotaxic Instrument
72d
Cleared
Oct 20, 2005
BRC SOFTWARE PRODUCT
OLU
Normalizing Quantitative Electroencephalograph Software
266d
Cleared
Oct 20, 2005
AURA-PSG
OLV
Standard Polysomnograph With Electroencephalograph
244d
Cleared
Oct 17, 2005
ICY CATHETER, MODEL IC-3893A
NCX
System, Hypothermia, Intravenous, Cooling
41d
Cleared
Oct 11, 2005
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A
NCX
System, Hypothermia, Intravenous, Cooling
89d
Cleared
Sep 27, 2005
DIGITAL HAND DYNAMOMETER, MODEL SH5003
LBB
Dynamometer, Ac-powered
34d
Cleared
Sep 27, 2005
ACTIHEART
GWK
Conditioner, Signal, Physiological
15d
Cleared
Sep 26, 2005
AXXESS BUTTERFLY ANCHOR
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
24d
Cleared
Sep 21, 2005
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
GZI
Stimulator, Neuromuscular, External Functional
27d
Cleared
Sep 20, 2005
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A
GWF
Stimulator, Electrical, Evoked Response
119d
Cleared
Sep 20, 2005
MAYFIELD INFINITY SKULL CLAMP
HBL
Holder, Head, Neurosurgical (skull Clamp)
110d
Cleared
Sep 16, 2005
BIOBANDS
MVV
Device, Acupressure
112d
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