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 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
Cleared
Mar 28, 2014
NEUROSTAR TMS THERAPY SYSTEM
OBP
Transcranial Magnetic Stimulator
142d
Cleared
Mar 27, 2014
BIOMET ACCESS SYSTEM
PDQ
Neurosurgical Nerve Locator
240d
Cleared
Mar 24, 2014
QB TEST
LQD
Recorder, Attention Task Performance
140d
Cleared
Mar 24, 2014
IOVERA
GXH
Device, Surgical, Cryogenic
132d
Cleared
Mar 20, 2014
VARIOGUIDE DRILL KIT
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
227d
Cleared
Mar 12, 2014
BODIHEALTH SYSTEM
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
278d
Not Cleared
Mar 11, 2014
CEFALY
PCC
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
453d
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