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Neurology devices
192 product codes reviewed by the Neurology panel. 6,150 510(k) clearances and 1,558 recalls in the FDA data, 84% of those recalls name a 510(k).
206510(k)s in 12 months
93recalls in 12 months
1,305recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 2 | 48 | 13 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 1 | 19 |
| HAW | Neurological Stereotaxic Instrument | 2 | 6 | 7 |
| GXY | Electrode, Cutaneous | 2 | 12 | 0 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 | 11 | 0 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 10 | 0 |
| OBP | Transcranial Magnetic Stimulator | 2 | 8 | 1 |
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | 2 | 0 | 8 |
| HCG | Device, Neurovascular Embolization | 2 | 5 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 3 | 2 |
| GWG | Endoscope, Neurological | 2 | 4 | 1 |
| GXI | Probe, Radiofrequency Lesion | 2 | 2 | 3 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 5 | 0 |
| JXG | Shunt, Central Nervous System And Components | 2 | 4 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 2 | 5 | 0 |
| GWM | Device, Monitoring, Intracranial Pressure | 2 | 1 | 3 |
| GXP | Methyl Methacrylate For Cranioplasty | 2 | 4 | 0 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 4 | 0 |
| SBF | Orthopedic Augmented Reality | 2 | 3 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 | 1 |
| GYD | Transducer, Tremor | 2 | 3 | 0 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 2 | 3 | 0 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | 2 | 0 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 | 0 |
| HBA | Neurosurgical Paddie | 2 | 0 | 2 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 2 | 1 | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | 1 | 1 |
| JXI | Cuff, Nerve | 2 | 2 | 0 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 | 0 |
| OLW | Index-Generating Electroencephalograph Software | 2 | 2 | 0 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 2 | 2 | 0 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 2 | 2 | 0 |
| OMC | Reduced- Montage Standard Electroencephalograph | 2 | 2 | 0 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 2 | 2 | 0 |
| QBC | External Upper Limb Tremor Stimulator | 2 | 2 | 0 |
| QFX | Diagnostic Neurosurgical Microscope Filter | 2 | 2 | 0 |
| QPF | Pediatric Autism Spectrum Disorder Diagnosis Aid | 2 | 2 | 0 |
| SEM | Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | 2 | 2 | 0 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 0 | 1 |
| GWL | Amplifier, Physiological Signal | 2 | 1 | 0 |
| GWN | Nystagmograph | 2 | 1 | 0 |
| GXD | Generator, Lesion, Radiofrequency | 2 | 1 | 0 |
| GXQ | Dura Substitute | 2 | 1 | 0 |
| GXR | Cover, Burr Hole | 2 | 1 | 0 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | 2 | 0 | 1 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | 2 | 1 | 0 |
| GZL | Electrode, Depth | 2 | 1 | 0 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 2 | 1 | 0 |
| HAE | Rongeur, Manual | 2 | 1 | 0 |
| HBB | Motor, Drill, Pneumatic | 2 | 1 | 0 |
| HBC | Motor, Drill, Electric | 2 | 1 | 0 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 2 | 1 | 0 |
| HBO | Clip, Scalp | 2 | 1 | 0 |
| HCC | Device, Biofeedback | 2 | 1 | 0 |
| LEL | Device, Sleep Assessment | 2 | 1 | 0 |
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | 2 | 1 | 0 |
| OLU | Normalizing Quantitative Electroencephalograph Software | 2 | 1 | 0 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | 1 | 0 |
| POM | Computerized Cognitive Assessment Aid For Concussion | 2 | 1 | 0 |
| POS | Physiological Signal Based Seizure Monitoring System | 2 | 1 | 0 |
| PPT | Cranial Surgical Planning And Instrument Guides | 2 | 1 | 0 |
| QCF | Electrical Tongue Stimulator To Treat Motor Deficits | 2 | 1 | 0 |
| QEA | Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid | 2 | 1 | 0 |
| QFF | Electromechanical Arm For A Transcranial Magnetic Stimulation System | 2 | 1 | 0 |
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | 2 | 0 | 1 |
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 2 | 1 | 0 |
| QRA | Virtual Reality Behavioral Therapy Device For Pain Relief | 2 | 1 | 0 |
| QWT | Prognostic Assessment Software Of Mild Cognitive Impairment | 2 | 1 | 0 |
| SAP | Computerized Behavioral Therapy Device For Depressive Disorders. | 2 | 1 | 0 |
| SCN | Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief | 2 | 1 | 0 |
| SGN | High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation | 2 | 1 | 0 |
| SHO | Parkinsonian Syndrome Diagnostic Aid | 2 | 1 | 0 |
| SHX | Transcranial Nerve Stimulation Device For The Treatment Of Post-Traumatic Stress Disorder Associated Symptoms | 2 | 1 | 0 |
| SIG | Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd) | 2 | 1 | 0 |
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