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
4716 Neurology devices
Cleared
Jun 03, 2014
AXON-BUS PROSTHETIC SYSTEM
GXY
Electrode, Cutaneous
540d
Cleared
May 30, 2014
CP RELIEF WAND
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
169d
Cleared
May 29, 2014
SENTIO MMG
PDQ
Neurosurgical Nerve Locator
387d
Cleared
May 28, 2014
REHASTIM 2, ERIGOPRO (FES)
GZI
Stimulator, Neuromuscular, External Functional
299d
Cleared
May 23, 2014
Best-AV2 Pro-Sport(tm)
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
598d
Cleared
May 21, 2014
SPRINGTMS TOTAL MIGRAINE SYSTEM
OKP
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
127d
Cleared
May 21, 2014
SKINTACT
GXY
Electrode, Cutaneous
99d
Cleared
May 20, 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
GXN
Plate, Cranioplasty, Preformed, Non-alterable
232d
Cleared
May 19, 2014
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
157d
Cleared
May 16, 2014
NUVASIVE NVM5 SYSTEM
PDQ
Neurosurgical Nerve Locator
260d
Cleared
May 13, 2014
PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
NRY
Catheter, Thrombus Retriever
197d
Cleared
May 02, 2014
NUVASIVE EMG ENDOTRACHEAL TUBE
PDQ
Neurosurgical Nerve Locator
168d
Cleared
May 02, 2014
SWIFT-LOCK ANCHOR
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
88d
Cleared
Apr 30, 2014
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
475d
Cleared
Apr 29, 2014
NEUROMATE FRAMELESS GEN II
HAW
Neurological Stereotaxic Instrument
238d
Cleared
Apr 24, 2014
NEURAGEN 3D
JXI
Cuff, Nerve
416d
Cleared
Apr 24, 2014
QUICK RELAX PRO
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
301d
Cleared
Apr 24, 2014
PINOOK STIMULATOR
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
252d
Cleared
Apr 24, 2014
COUNTER OTC TENS DEVICE
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
212d
Cleared
Apr 18, 2014
P-POD
MVA
Orthosis, Cranial
163d
Cleared
Apr 17, 2014
NUFACE MINI DEVICE
NFO
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
121d
Cleared
Apr 11, 2014
RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
PDQ
Neurosurgical Nerve Locator
274d
Cleared
Apr 10, 2014
IEEG
OMC
Reduced- Montage Standard Electroencephalograph
287d
Cleared
Apr 03, 2014
FLEXIBLE COOAGEN NERVE CUFF
JXI
Cuff, Nerve
309d
Cleared
Mar 31, 2014
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
GXQ
Dura Substitute
201d
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