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
Sep 15, 2011
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
GZI
Stimulator, Neuromuscular, External Functional
84d
Cleared
Sep 15, 2011
TRAGET DETACHABLE COIL
HCG
Device, Neurovascular Embolization
28d
Cleared
Sep 13, 2011
REUSABLE STIMULATING ELECTRODES
GXY
Electrode, Cutaneous
133d
Cleared
Aug 30, 2011
FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE
GXY
Electrode, Cutaneous
210d
Cleared
Aug 30, 2011
ZYTO HAND CRADLE
GZO
Device, Galvanic Skin Response Measurement
112d
Cleared
Aug 29, 2011
HARMONIE SYSTEM
GWQ
Full-montage Standard Electroencephalograph
999d
Cleared
Aug 24, 2011
LIFECARE CONDUCTIVE GARMENTS
GXY
Electrode, Cutaneous
246d
Cleared
Aug 22, 2011
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
MOF
Guide, Wire, Catheter, Neurovasculature
174d
Cleared
Aug 22, 2011
BOSTON BAND
MVA
Orthosis, Cranial
74d
Cleared
Aug 19, 2011
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
GXI
Probe, Radiofrequency Lesion
15d
Cleared
Aug 15, 2011
OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM
GWO
Plate, Cranioplasty, Preformed, Alterable
110d
Cleared
Aug 15, 2011
CRANIAL REMOLDING ORTHOSIS
MVA
Orthosis, Cranial
104d
Cleared
Aug 12, 2011
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
IKT
Electrode, Needle, Diagnostic Electromyograph
28d
Cleared
Aug 04, 2011
MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
GYC
Electrode, Cortical
171d
Cleared
Aug 03, 2011
KNEEHAB XP
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
177d
Cleared
Aug 03, 2011
CARE BACK PAIN RELIEF STIMULATOR
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
142d
Cleared
Aug 02, 2011
LO-BAK TRAX
HST
Apparatus, Traction, Non-powered
127d
Cleared
Jul 29, 2011
PAIN BUDDY
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
373d
Cleared
Jul 29, 2011
PE-210AK SWITCH BOX
GWQ
Full-montage Standard Electroencephalograph
170d
Cleared
Jul 29, 2011
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
168d
Cleared
Jul 28, 2011
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
GXZ
Electrode, Needle
164d
Cleared
Jul 25, 2011
CIRCUMAURAL ADHESIVE REPLACEMENT
GWJ
Stimulator, Auditory, Evoked Response
52d
Cleared
Jul 19, 2011
ENTROPY EASYFIT SENSOR
GWQ
Full-montage Standard Electroencephalograph
270d
Cleared
Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
JXG
Shunt, Central Nervous System And Components
416d
Cleared
Jun 30, 2011
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
OMC
Reduced- Montage Standard Electroencephalograph
85d
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