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
Apr 23, 2013
MAYFIELD INFINITY XR2 SKULL CLAMP
HBL
Holder, Head, Neurosurgical (skull Clamp)
67d
Cleared
Apr 17, 2013
SLEEP PROFILER
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
105d
Cleared
Apr 16, 2013
PAINMASTER MCT PATCH
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
90d
Cleared
Apr 11, 2013
JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS
BWK
Stimulator, Electro-acupuncture
210d
Cleared
Apr 05, 2013
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
267d
Cleared
Apr 05, 2013
HEARLAB ACA
GWJ
Stimulator, Auditory, Evoked Response
123d
Cleared
Apr 05, 2013
NEURO OMEGA SYSTEM
GZL
Electrode, Depth
116d
Cleared
Apr 01, 2013
WALKAIDE SYSTEM
GZI
Stimulator, Neuromuscular, External Functional
96d
Cleared
Mar 29, 2013
D4000 DRIVE SYSTEM
HBC
Motor, Drill, Electric
31d
Cleared
Mar 28, 2013
PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
202d
Cleared
Mar 28, 2013
STRYKER VENOM ELECTRODES AND CANNULAE
GXI
Probe, Radiofrequency Lesion
170d
Cleared
Mar 28, 2013
BARRICADE EMBOLIZATION COIL SYSTEM
HCG
Device, Neurovascular Embolization
148d
Cleared
Mar 25, 2013
LIFELINES IEEG
OLT
Non-normalizing Quantitative Electroencephalograph Software
117d
Cleared
Mar 22, 2013
MRII CRAINIAL DRILL
HBG
Drills, Burrs, Trephines & Accessories (manual)
221d
Cleared
Mar 19, 2013
CADWELL DISPOSABLE PROBE HANDLE
PDQ
Neurosurgical Nerve Locator
118d
Cleared
Mar 07, 2013
SHUNTCHECK
JXG
Shunt, Central Nervous System And Components
108d
Cleared
Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
JXG
Shunt, Central Nervous System And Components
90d
Cleared
Feb 07, 2013
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
GXN
Plate, Cranioplasty, Preformed, Non-alterable
232d
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
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