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
4737 Neurology devices
Cleared
May 04, 2005
NEUROLAC NERVE GUIDE
JXI
Cuff, Nerve
58d
Cleared
Apr 29, 2005
ELECTRODE JUNCTION BOX, MODEL JE-921A
OLV
Standard Polysomnograph With Electroencephalograph
28d
Cleared
Apr 27, 2005
EKOS ULTRASOUND INFUSION SYSTEM
NUI
Ultrasound, Infusion, System
294d
Cleared
Apr 27, 2005
EPIGUARD
JXL
Block, Bite
90d
Cleared
Apr 27, 2005
NEXUS DETACHABLE COIL SYSTEM
HCG
Device, Neurovascular Embolization
56d
Cleared
Apr 27, 2005
AESCULAP ORTHOPILOT 2 THA V 2.0
HAW
Neurological Stereotaxic Instrument
35d
Cleared
Apr 26, 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
GXZ
Electrode, Needle
89d
Cleared
Apr 21, 2005
STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000
HAW
Neurological Stereotaxic Instrument
43d
Cleared
Apr 21, 2005
TRIAL CABLE RETENTION CLIP
GZB
Stimulator, Spinal-cord, Implanted (pain Relief)
41d
Cleared
Apr 21, 2005
NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000
HAW
Neurological Stereotaxic Instrument
27d
Cleared
Apr 19, 2005
KOLIBRI SPINE
HAW
Neurological Stereotaxic Instrument
200d
Cleared
Apr 15, 2005
MATRIX STRETCH RESISTANT (SR) COILS
HCG
Device, Neurovascular Embolization
28d
Cleared
Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
GZT
Retractor, Self-retaining, For Neurosurgery
28d
Cleared
Apr 07, 2005
NBD HEAD SCREW
HAW
Neurological Stereotaxic Instrument
51d
Cleared
Apr 07, 2005
ANSPACH COUPLER
HBE
Drills, Burrs, Trephines & Accessories (simple, Powered)
27d
Cleared
Apr 06, 2005
MICROWARE 200
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
15d
Cleared
Mar 31, 2005
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104
HBL
Holder, Head, Neurosurgical (skull Clamp)
50d
Cleared
Mar 29, 2005
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
GZL
Electrode, Depth
209d
Cleared
Mar 28, 2005
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM
GWQ
Full-montage Standard Electroencephalograph
182d
Cleared
Mar 24, 2005
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
GXH
Device, Surgical, Cryogenic
48d
Cleared
Mar 18, 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
GZL
Electrode, Depth
214d
Cleared
Mar 17, 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
GXI
Probe, Radiofrequency Lesion
63d
Cleared
Mar 16, 2005
ENFANTTM
GWE
Stimulator, Photic, Evoked Response
89d
Cleared
Mar 14, 2005
MODEL BMLS03-7
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
165d
Cleared
Mar 09, 2005
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
217d
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