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
Not Cleared
Nov 07, 2014
ZANZA-CLICK
OSG
Piezo-electric Stimulator For Relief Of Mosquito Bite Itch
617d
Cleared
Nov 05, 2014
E-Shield Multi-paried Subdermal Needle Electrodes
GXZ
Electrode, Needle
63d
Cleared
Oct 22, 2014
SOLITAIRE 2 REVASCULARIZATION DEVICE
NRY
Catheter, Thrombus Retriever
139d
Cleared
Oct 15, 2014
DANA
LQD
Recorder, Attention Task Performance
97d
Cleared
Oct 10, 2014
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
135d
Cleared
Oct 10, 2014
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT
GWM
Device, Monitoring, Intracranial Pressure
91d
Cleared
Oct 06, 2014
STARBAND, STARLIGHT
MVA
Orthosis, Cranial
90d
Cleared
Oct 03, 2014
CRANIOPLUG
GXR
Cover, Burr Hole
238d
Cleared
Oct 03, 2014
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
NCX
System, Hypothermia, Intravenous, Cooling
154d
Cleared
Oct 02, 2014
Electro Auricular Device
BWK
Stimulator, Electro-acupuncture
212d
Cleared
Sep 26, 2014
MEDLINE NEURO SPONGE
HBA
Neurosurgical Paddie
224d
Cleared
Sep 25, 2014
PHANTOM XL INSULATED DILATORS
PDQ
Neurosurgical Nerve Locator
254d
Cleared
Sep 17, 2014
ELECTRONIC PULSE STIMULATOR
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
125d
Cleared
Sep 04, 2014
HFD100 ROCKER ARM ACCESSORY
HBL
Holder, Head, Neurosurgical (skull Clamp)
48d
Cleared
Aug 28, 2014
EASYSTIM TN28_OTC
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
217d
Cleared
Aug 26, 2014
TENS
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
243d
Cleared
Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
GYD
Transducer, Tremor
220d
Cleared
Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,
GWJ
Stimulator, Auditory, Evoked Response
81d
Not Cleared
Aug 22, 2014
Medtronic DUET External Drainage and Monitoring System
PCB
External Cerebrospinal Fluid (csf) Diversion
609d
Cleared
Aug 08, 2014
WALKAIDE SYSTEM
GZI
Stimulator, Neuromuscular, External Functional
123d
Cleared
Aug 06, 2014
IQ TECHNOLOGIES
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
457d
Cleared
Jul 31, 2014
TRAXCESS 14 GUIDEWIRE
MOF
Guide, Wire, Catheter, Neurovasculature
237d
Cleared
Jul 25, 2014
BNA ANALYSIS SYSTEM
OLU
Normalizing Quantitative Electroencephalograph Software
834d
Cleared
Jul 25, 2014
HIVOX SELF ADHESIVE ELECTRODE GEL PADS
GXY
Electrode, Cutaneous
408d
Cleared
Jul 25, 2014
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
HAW
Neurological Stereotaxic Instrument
255d
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