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Neurology devices
192 product codes reviewed by the Neurology panel. 6,142 510(k) clearances and 1,558 recalls in the FDA data, 84% of those recalls name a 510(k).
206510(k)s in 12 months
95recalls in 12 months
1,305recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 258 | 19 |
| HAW | Neurological Stereotaxic Instrument | 202 | 8 |
| OLO | Orthopedic Stereotaxic Instrument | 115 | 13 |
| JXG | Shunt, Central Nervous System And Components | 108 | 1 |
| OJG | Neurological Tray | 94 | 24 |
| HBA | Neurosurgical Paddie | 78 | 2 |
| HCG | Device, Neurovascular Embolization | 68 | 2 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 54 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 52 | 3 |
| HBC | Motor, Drill, Electric | 39 | 0 |
| GXP | Methyl Methacrylate For Cranioplasty | 30 | 0 |
| GXI | Probe, Radiofrequency Lesion | 29 | 3 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 24 | 0 |
| GZL | Electrode, Depth | 24 | 0 |
| GWQ | Full-Montage Standard Electroencephalograph | 23 | 1 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 2 | 48 | 13 |
| OJG | Neurological Tray | 1 | 0 | 24 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 2 | 19 |
| HAW | Neurological Stereotaxic Instrument | 2 | 5 | 8 |
| GXY | Electrode, Cutaneous | 2 | 12 | 0 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 11 | 0 |
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | 2 | 10 | 0 |
| OBP | Transcranial Magnetic Stimulator | 2 | 9 | 1 |
| SFD | In Situ Polymerizing Peripheral Nerve Repair Device | 2 | 0 | 8 |
| HCG | Device, Neurovascular Embolization | 2 | 5 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 6 | 0 |
| JXG | Shunt, Central Nervous System And Components | 2 | 5 | 1 |
| GWF | Stimulator, Electrical, Evoked Response | 2 | 3 | 2 |
| GWG | Endoscope, Neurological | 2 | 4 | 1 |
| GXI | Probe, Radiofrequency Lesion | 2 | 2 | 3 |
| 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 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 2 | 3 | 1 |
| SBF | Orthopedic Augmented Reality | 2 | 3 | 1 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 | 1 |
| GYD | Transducer, Tremor | 2 | 3 | 0 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | 2 | 0 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 | 0 |
| GZL | Electrode, Depth | 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 |
| GWJ | Stimulator, Auditory, Evoked Response | 2 | 0 | 1 |
| GWN | Nystagmograph | 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 |
| 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 |
| 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 |
| QEO | Light Attenuation Lenses For Migraine-Associated Light Sensitivity | 1 | 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 |
| SEM | Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring | 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 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Stryker Leibinger GmbH & Co. KG Precision Pointer Electromagnetic (8000-050-001) Open, Classified |
HAW | K212194 |
| Oct 29, 2026 | Boston Scientific Neuromodulation Corporation Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System Open, Classified |
GZB | K233801 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly Open, Classified |
HAW | K971247 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Medtronic Navigation, Inc. Medtronic NDI Passive Spheres
REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly Open, Classified |
HAW | K033621 |
| Oct 16, 2026 | Think Surgical, Inc. Think Surgical Square Driver
REF: 109126 Open, Classified |
OLO | K261024 |
| Oct 15, 2026 | Medline Industries, LP Medline surgical convenience kits labeled as:
1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A;
2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M. Open, Classified |
OJG | None listed |
| Oct 9, 2026 | Neuronetics, Inc. NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems:
1. NeuroStar 2.0 US; Part Number: 81-01315-0 Open, Classified |
OBP | K231926 K233621 |
| Oct 9, 2026 | Cadwell Industries Inc Brand Name: IOMAX
Product Name: IOMAX Cortical Module
Model/Catalog Number: 190296-200
UDI-DI code: 00840067100653
Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low Open, Classified |
GWF | K162199 |
| Oct 7, 2026 | Intellijoint Surgical, Inc. Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249 Open, Classified |
OLO | K191507 |
| Oct 7, 2026 | AVID Medical, Inc. CRANIOTOMY PACK;
Model/Item Number (Kit): WRNM035-20; Open, Classified |
OJG | None listed |
| Sep 24, 2026 | Medline Industries, LP Medline Convenience Kits:
1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I;
2) NEURO PACK-LF, Catalog Number: DYNJ41246F;
3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A;
4) MAJOR NEURO Open, Classified |
OJG | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ASLMC CRANIOTOMY , Catalog Number: PNCGCNAUM;
2) KIT, ORP MAJOR SPINE , Catalog Number: Open, Classified |
OJG | None listed |
| Sep 2, 2026 | Medos International Sarl Velys Enabling Tech Robotic-Assist Station
REF: 451611001 Open, Classified |
OLO | K233228 |
| Aug 28, 2026 | AVID Medical, Inc. 1) NEURO, (kit) ACNE73-01;
2) NEURO, (kit) ACNE73-03;
3) CRANI, (kit) AKCR19-01;
4) ORTHO SPINE PACK, (kit) ARMC017;
5) BMHM NEURO PACK, (kit) BMHT016-05;
6) LUMBAR PACK, (kit) BMHT112-03;
7) NE Open, Classified |
OJG | None listed |
| Aug 21, 2026 | Medline Industries, LP Medline medical convenience kits, labeled as:
1) NEURO CDS, Medline Kit SKU CDS985246J;
2) NEURO PACK, Medline Kit SKU DYNJ32770V;
3) NEURO BUNDLE-LF, Medline Kit SKU DYNJ40095D;
4) NEURO PACK-LF Open, Classified |
OJG | None listed |
| Aug 20, 2026 | American Contract Systems Inc American Contract Systems medical procedure kits and trays labeled as:
1) CRANI PACK - 208400, Model Item Number UDCP57AI;
2) SPINE PACK, Model Item Number HSLM53AC;
3) CRANIAL PACK - 205992, Mode Open, Classified |
OJG | None listed |
| Aug 14, 2026 | Kico Knee Innovation Company Brand Name: Kico Knee Innovation
Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2
Model/Catalog Number: IN-29200
Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200)
ARVIS S Open, Classified |
SBF | K243950 K243980 |
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27;
2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28;
3) CHI STD NEURO CRANI OPT 2 , Catal Open, Classified |
OJG | None listed |
| Aug 6, 2026 | TISSIUM SA Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO6010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No Open, Classified |
SFD | None listed |
| Aug 6, 2026 | TISSIUM SA Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO5010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No Open, Classified |
SFD | None listed |
| Aug 6, 2026 | TISSIUM SA Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO4010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No Open, Classified |
SFD | None listed |
| Aug 6, 2026 | TISSIUM SA Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO3010
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No Open, Classified |
SFD | None listed |
| Aug 6, 2026 | TISSIUM SA Brand Name: COAPTIUM CONNECT
Product Name: COAPTIUM CONNECT
Model/Catalog Number: NCOCO2075
Software Version: N/A
Product Description: In situ polymerizing peripheral nerve repair device
Component: No Open, Classified |
SFD | None listed |
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