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
6334
Total
6279
Cleared
155d
Avg (2y)
1976
Since
6334 Neurology devices
Cleared
May 21, 2007
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
HBL
Holder, Head, Neurosurgical (skull Clamp)
182d
Cleared
May 09, 2007
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
223d
Cleared
May 09, 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
NCX
System, Hypothermia, Intravenous, Cooling
30d
Cleared
May 07, 2007
TOP-RANK ADHESIVE ELECTRODE
GXY
Electrode, Cutaneous
63d
Cleared
Apr 30, 2007
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
236d
Cleared
Apr 27, 2007
STRYKER TWIST DRILLS
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
29d
Cleared
Apr 25, 2007
NEWLIFE SCIENCES LLC, MODEL TMR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
64d
Cleared
Apr 24, 2007
FX DETACHABLE COIL SYSTEM
HCG
Device, Neurovascular Embolization
400d
Cleared
Apr 24, 2007
MODIFIED MERCY RETRIEVER, MODEL 90070
NRY
Catheter, Thrombus Retriever
60d
Cleared
Apr 23, 2007
VV FLUORO 3D
HAW
Neurological Stereotaxic Instrument
102d
Cleared
Apr 17, 2007
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
HCH
Clip, Aneurysm
378d
Cleared
Apr 16, 2007
MICROBLADE SHAVER AND ACCESSORIES
HAE
Rongeur, Manual
173d
Cleared
Apr 13, 2007
RS-4I MUSCLE STIMULATOR FAMILY
NYN
Stimulator, Electrical, Transcutaneous, For Arthritis
247d
Cleared
Apr 11, 2007
STATIC CRANIOPLASTY ORTHOSIS
OAN
Orthosis, Cranial, Laser Scan
183d
Cleared
Apr 11, 2007
TRIAL CABLE, 3009
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
14d
Cleared
Apr 06, 2007
KINESIA
GYD
Transducer, Tremor
98d
Cleared
Apr 06, 2007
MICRUS MICROCOIL SYSTEM
HCG
Device, Neurovascular Embolization
23d
Cleared
Apr 05, 2007
ARGOS
HAW
Neurological Stereotaxic Instrument
310d
Cleared
Apr 05, 2007
CES ULTRA
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
241d
Cleared
Mar 30, 2007
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM
GWN
Nystagmograph
15d
Cleared
Mar 22, 2007
PORTI 7 PHYSIOLOGICAL AMPLIFIER
GWL
Amplifier, Physiological Signal
108d
Cleared
Mar 21, 2007
QUADRA BLOC TENS, MODEL 101
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
203d
Cleared
Mar 07, 2007
ULTRA LOW PROFILE RONGEUR
HAE
Rongeur, Manual
177d
Cleared
Feb 28, 2007
CTLOGICS NAVIGATIONS SYSTEMS
HAW
Neurological Stereotaxic Instrument
107d
Cleared
Feb 16, 2007
DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED
IKT
Electrode, Needle, Diagnostic Electromyograph
189d
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