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
Mar 10, 2010
FIXIT HEADREST CLAMP SYSTEM
HBL
Holder, Head, Neurosurgical (skull Clamp)
443d
Cleared
Mar 03, 2010
GRINDCARE
HCC
Device, Biofeedback
183d
Cleared
Feb 22, 2010
NATUS NEUROWORKS, MODEL 104196
OMB
Automatic Event Detection Software For Full-montage Electroencephalograph
416d
Cleared
Feb 17, 2010
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
HAE
Rongeur, Manual
209d
Cleared
Feb 12, 2010
WAYPOINT STEREOTACTIC SYSTEM
HAW
Neurological Stereotaxic Instrument
206d
Cleared
Feb 05, 2010
OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
234d
Cleared
Feb 04, 2010
TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM
HCG
Device, Neurovascular Embolization
122d
Cleared
Jan 29, 2010
STATNET, MODEL 3100
GXY
Electrode, Cutaneous
137d
Cleared
Jan 22, 2010
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
JXG
Shunt, Central Nervous System And Components
262d
Cleared
Jan 22, 2010
OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
GXD
Generator, Lesion, Radiofrequency
105d
Cleared
Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
JXG
Shunt, Central Nervous System And Components
30d
Cleared
Jan 21, 2010
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
GXQ
Dura Substitute
169d
Cleared
Jan 21, 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
HCG
Device, Neurovascular Embolization
30d
Cleared
Jan 15, 2010
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
GWQ
Full-montage Standard Electroencephalograph
94d
Cleared
Jan 15, 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
HCG
Device, Neurovascular Embolization
79d
Cleared
Jan 13, 2010
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
IKT
Electrode, Needle, Diagnostic Electromyograph
30d
Cleared
Jan 07, 2010
INF 4160 PLUS, MODEL D-FJ31F
LIH
Interferential Current Therapy
119d
Cleared
Jan 06, 2010
MICHIGAN CRANIAL RESHAPING ORTHOSIS
MVA
Orthosis, Cranial
330d
Cleared
Dec 23, 2009
SWIFT-LOCK ANCHOR, MODEL 1192
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
140d
Cleared
Dec 22, 2009
DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE
GXY
Electrode, Cutaneous
189d
Cleared
Dec 18, 2009
SMART TENS, MODEL: D-BC05T
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
249d
Cleared
Dec 18, 2009
GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
GXY
Electrode, Cutaneous
121d
Cleared
Dec 08, 2009
NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
GWF
Stimulator, Electrical, Evoked Response
389d
Cleared
Dec 08, 2009
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
GWF
Stimulator, Electrical, Evoked Response
204d
Cleared
Dec 07, 2009
E-PULSE
BWK
Stimulator, Electro-acupuncture
167d
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