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NAVIGATION SYSTEM II · Neurology

510(k): 0 Recall: 0 UDI: 0 MAUDE: 10 Class.: 62

MAUDE Adverse Events (10)

Malfunction
20110919
Malfunction
20110617
Malfunction
20110526
Malfunction
20110412
Malfunction
20110223
Malfunction
20110111
Malfunction
20110104
Injury
20090720
Malfunction
20090715
Injury
20090127

FDA Classification (62)

Orthopedic Stereotaxic Instrument

Neurology

Drills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed

Neurology

Electrode, Cutaneous

Neurology

Catheter, Intravascular Occluding

Neurology

Endoscopic Shunt Placement Kit

Neurology

Conditioner, Signal, Physiological

Neurology

Generator, Lesion, Radiofrequency

Neurology

Stimulator, Mechanical, Evoked Response

Neurology

Non-Invasive Evoked Response Brain Stimulator

Neurology

In Situ Polymerizing Peripheral Nerve Cap

Neurology

Cranial Electrotherapy Stimulator To Treat Depression

Neurology

Block, Bite

Neurology

Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder

Neurology

Transcutaneous Nerve Stimulator For Adhd

Neurology

Chair, Neurosurgical

Neurology

Computerized Cognitive Assessment Aid For Concussion

Neurology

Field Generator Positioning Device

Neurology

Leukotome

Neurology

Neuromuscular Stimulator And Exercise Evaluation System

Neurology

Device, Monitoring, Intracranial Pressure

Neurology

Cranial Surgical Planning And Instrument Guides

Neurology

Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)

Neurology

Tracking, Soft Tissue, Intraoperative

Neurology

Device, Surgical, Cryogenic

Neurology

Clip, Aneurysm

Neurology

Thermal Vestibular Stimulator For Headache

Neurology

Amplitude-Integrated Electroencephalograph

Neurology

Electromagnetic Stimulator, Pain Relief

Neurology

Computerized Behavioral Therapy Device For Anxiety Disorders

Neurology

Computer Assisted Hair Harvesting System

Neurology

Nystagmograph

Neurology

Holder, Head, Neurosurgical (Skull Clamp)

Neurology

Device, Sleep Assessment

Neurology

Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Neurology

Anvil, Skull Plate

Neurology

Burst Suppression Detection Software For Electroencephalograph

Neurology

Rongeur, Powered

Neurology

Patient Specific Manual Orthopedic Stereotaxic System

Neurology

Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms

Neurology

Rongeur, Manual

Neurology

Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch

Neurology

Electrode, Spinal Epidural

Neurology

Index-Generating Electroencephalograph Software

Neurology

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Neurology

Computerized Behavioral Therapy Device For Migraine

Neurology

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

Neurology

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Neurology

Stimulator, Nerve, Transcutaneous, For Pain Relief

Neurology

Normalizing Quantitative Electroencephalograph Software

Neurology

Brain Intraparenchymal Infusion Cannula

Neurology

Pinwheel

Neurology

Parkinsonian Syndrome Diagnostic Aid

Neurology

Needle, Neurosurgical Suture

Neurology

Cranial Distraction System

Neurology

Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

Neurology

Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

Neurology

Evoked Photon Image Capture Device

Neurology

Instrument, Dowel Cutting

Neurology

Instrument, Surgical, Non-Powered

Neurology

Automatic Event Detection Software For Full-Montage Electroencephalograph

Neurology

Catheter, Neuro-Vasculature, Occluding Balloon

Neurology

Pain Assessment Software In Non-Communicative Adults

Neurology