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
Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
JXG
Shunt, Central Nervous System And Components
26d
Cleared
May 29, 2009
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
QJQ
Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
142d
Cleared
May 28, 2009
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
GWL
Amplifier, Physiological Signal
52d
Cleared
May 27, 2009
NEUROMETRIX BIOAMPLIFIER
GWL
Amplifier, Physiological Signal
196d
Cleared
May 22, 2009
FREEDOM STIM 100 AND 200 ELECTRODE AND LEADWIRE EXTENSION
GXY
Electrode, Cutaneous
183d
Cleared
May 15, 2009
NEUCODIA
GWE
Stimulator, Photic, Evoked Response
343d
Cleared
May 08, 2009
CRANIAL IMAGE GUIDED SURGERY SYSTEM
HAW
Neurological Stereotaxic Instrument
291d
Cleared
May 08, 2009
PMT SUBDURAL CORTICAL ELECTRODES
GYC
Electrode, Cortical
253d
Cleared
May 08, 2009
FLEX-TENS
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
51d
Cleared
May 06, 2009
GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
HCH
Clip, Aneurysm
329d
Cleared
May 06, 2009
LASER TOUCHONE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
135d
Cleared
May 06, 2009
PAINMASTER MCT PATCH
NUH
Stimulator, Nerve, Transcutaneous, Over-the-counter
120d
Cleared
May 01, 2009
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
HAW
Neurological Stereotaxic Instrument
445d
Cleared
Apr 29, 2009
PRIMADO
HBC
Motor, Drill, Electric
190d
Cleared
Apr 23, 2009
DINKLER SURGICAL SKULL CLAMP, MODEL 0308
HBL
Holder, Head, Neurosurgical (skull Clamp)
38d
Cleared
Apr 21, 2009
TENS/NMES/FES STIMULATING ELECTRODE
GXY
Electrode, Cutaneous
159d
Cleared
Apr 20, 2009
MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114
HBL
Holder, Head, Neurosurgical (skull Clamp)
54d
Cleared
Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
GXY
Electrode, Cutaneous
262d
Cleared
Apr 10, 2009
HYDROFRAME (HES)
HCG
Device, Neurovascular Embolization
57d
Cleared
Mar 26, 2009
MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700
HBB
Motor, Drill, Pneumatic
69d
Cleared
Mar 19, 2009
ACTICARE IC AND TSE
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
265d
Cleared
Mar 18, 2009
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
GZT
Retractor, Self-retaining, For Neurosurgery
42d
Cleared
Mar 12, 2009
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
HCG
Device, Neurovascular Embolization
48d
Cleared
Mar 11, 2009
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298
GZJ
Stimulator, Nerve, Transcutaneous, For Pain Relief
219d
Cleared
Mar 06, 2009
EVOX ELECTRO DIAGNOSTIC DEVICE
GWF
Stimulator, Electrical, Evoked Response
178d
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