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
4720 Neurology devices
Cleared
Feb 06, 2013
EEGER4 MODEL 4.3
HCC
Device, Biofeedback
140d
Cleared
Feb 01, 2013
ICS IMPULSE
GWN
Nystagmograph
164d
Cleared
Jan 31, 2013
X4 SYSTEM
OMC
Reduced- Montage Standard Electroencephalograph
29d
Cleared
Jan 25, 2013
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE
GXY
Electrode, Cutaneous
436d
Cleared
Jan 25, 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
HCG
Device, Neurovascular Embolization
67d
Cleared
Jan 18, 2013
NEUROPACE BURR HOLE COVER MODEL 8110
GXR
Cover, Burr Hole
101d
Cleared
Jan 18, 2013
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
87d
Cleared
Jan 17, 2013
RESORB-X G
GWO
Plate, Cranioplasty, Preformed, Alterable
230d
Cleared
Jan 11, 2013
INFRASCANNER
OPT
Infrared Hematoma Detector
287d
Cleared
Jan 11, 2013
POWEREASE SYSTEM
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
84d
Cleared
Jan 10, 2013
CRYO-TOUCH IV
GXH
Device, Surgical, Cryogenic
57d
Cleared
Jan 07, 2013
BRAINSWAY DEEP TMS SYSTEM
OBP
Transcranial Magnetic Stimulator
161d
Cleared
Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
GZI
Stimulator, Neuromuscular, External Functional
107d
Cleared
Dec 21, 2012
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
LIH
Interferential Current Therapy
88d
Cleared
Dec 21, 2012
GEM-STIM COMBO STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
88d
Cleared
Dec 20, 2012
g.HIamp
GWL
Amplifier, Physiological Signal
63d
Cleared
Dec 19, 2012
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
226d
Cleared
Dec 19, 2012
PMT TRUSCAN SURFACE ELECTRODE
GXY
Electrode, Cutaneous
135d
Cleared
Dec 17, 2012
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
HAW
Neurological Stereotaxic Instrument
145d
Cleared
Nov 30, 2012
TARGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
29d
Cleared
Nov 30, 2012
SOLITAIRE 2 REVASCULARIZATION DEVICE
NRY
Catheter, Thrombus Retriever
29d
Cleared
Nov 26, 2012
SENSUS ELECTRODE
GXY
Electrode, Cutaneous
159d
Cleared
Nov 21, 2012
VECTTOR VT-200
LIH
Interferential Current Therapy
169d
Cleared
Nov 20, 2012
HEALTHMATEFOREVER
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
158d
Cleared
Nov 09, 2012
PSG-1100 SLEEP DIAGNOSTIC SYSTEM
GWQ
Full-montage Standard Electroencephalograph
231d
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