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
4727 Neurology devices
Cleared
Feb 06, 2008
ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
HAW
Neurological Stereotaxic Instrument
118d
Cleared
Feb 05, 2008
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
GWN
Nystagmograph
175d
Cleared
Feb 05, 2008
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
GWJ
Stimulator, Auditory, Evoked Response
41d
Cleared
Feb 01, 2008
NTRAINER SYSTEM
HCC
Device, Biofeedback
210d
Cleared
Feb 01, 2008
HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
183d
Cleared
Jan 30, 2008
SMALL LUMEN PERITONEAL CATHETER
JXG
Shunt, Central Nervous System And Components
84d
Cleared
Jan 25, 2008
ALGO 5 NEWBORN HEARING SCREENER
GWJ
Stimulator, Auditory, Evoked Response
30d
Cleared
Jan 24, 2008
MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS)
HAW
Neurological Stereotaxic Instrument
115d
Cleared
Jan 22, 2008
BOSTON-BAND CRANIAL REMODLING ORTHOSIS
OAN
Orthosis, Cranial, Laser Scan
109d
Cleared
Jan 11, 2008
EEG-1100A SWITCH BOX
OLV
Standard Polysomnograph With Electroencephalograph
30d
Cleared
Jan 10, 2008
MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES
OLV
Standard Polysomnograph With Electroencephalograph
192d
Cleared
Jan 09, 2008
HANGER CRANIAL BAND
OAN
Orthosis, Cranial, Laser Scan
119d
Cleared
Jan 04, 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
HBF
Drills, Burrs, Trephines & Accessories (compound, Powered)
37d
Cleared
Dec 28, 2007
PENUMBRA SYSTEM
NRY
Catheter, Thrombus Retriever
94d
Cleared
Dec 27, 2007
POLYBONE
GXP
Methyl Methacrylate For Cranioplasty
358d
Cleared
Dec 27, 2007
REHASTIM & REHAMOVE
GZI
Stimulator, Neuromuscular, External Functional
41d
Cleared
Dec 21, 2007
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
GXY
Electrode, Cutaneous
477d
Cleared
Dec 20, 2007
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
GXD
Generator, Lesion, Radiofrequency
204d
Cleared
Dec 19, 2007
PATIENT CONTOURED MESH-PEEK (PCM-P)
GXN
Plate, Cranioplasty, Preformed, Non-alterable
85d
Cleared
Dec 18, 2007
STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE
HAW
Neurological Stereotaxic Instrument
125d
Cleared
Dec 18, 2007
SYNTHES (USA) 2.0MM TITANIUM T-PLATE
GWO
Plate, Cranioplasty, Preformed, Alterable
81d
Cleared
Dec 10, 2007
TOTAL HIP SURGETICS NAVIGATION SYSTEM
HAW
Neurological Stereotaxic Instrument
117d
Cleared
Dec 10, 2007
OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
GXP
Methyl Methacrylate For Cranioplasty
87d
Cleared
Dec 07, 2007
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
154d
Cleared
Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
JXG
Shunt, Central Nervous System And Components
52d
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