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Catalogue (356)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega with NeuroOmega Drive | Neuro Omega with NeuroOmega Drive | FDA UDI | Class II | Active |
| NeuroNav Drive Headstage Kit | NeuroNav Drive Headstage Kit | FDA UDI | Class II | Active |
| Power cable | Plug Type E&F | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| NeuroSmart Autoclavable Drive Headstage Kit | NeuroSmart Autoclavable Drive Headstage Kit | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Frame adapter thumb screw - Pack of 3 | Frame adapter thumb screw - Pack of 3 | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-Shielded | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega LeadConfirm A Adaptor | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroSmart NeuroForits Drive Headstage | NeuroSmart NeuroForits Drive Headstage | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 3 channels MER only | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Power cable | Plug Type N-4 mm | FDA UDI | Class II | Active |
| NeuroSmart MER Headstage | NeuroSmart MER Headstage | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 5 channels | FDA UDI | Class II | Active |
| Neuro Omega | Neuro Omega ECoG Recording Kit | FDA UDI | Class II | Active |
| Cannula | Insertion Tube Set 40mm above | FDA UDI | Class II | Active |
| NexFrame Mechanical Set Kit | NexFrame Mechanical Set KIT | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroSmart Autoclavable Drive Headstage | Rev. 5 | FDA UDI | Class II | Active |
| Neuro Omega HS | Neuro Omega HS | FDA UDI | Class II | Active |
| NeuroNav with Autoclavable Drive Headstage (AutoClavable) | NeuroNav with Autoclavable Drive Headstage (AutoClavable) | FDA UDI | Class II | Active |
| Neuro Omega ECOG HeadBox Kit | Neuro Omega ECOG HeadBox Kit | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega LeadConfirm A Cable | FDA UDI | Class II | Active |
| NeuroFortis Neuro Omega Drive Headstage KIT | NeuroFortis Neuro Omega Drive Headstage KIT | FDA UDI | Class II | Active |
| Neuro Omega Drive Headstage Kit | Neuro Omega Drive Headstage Kit | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) | NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega | Neuro Omega ECoG- Recording with Full Stimulation Source | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroOmega Drive Headstage Kit | NeuroOmega Drive Headstage Kit | FDA UDI | Class II | Active |
| Neuro Omega MER Headstage | Neuro Omega MER Headstage | FDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 4, 2018 | Z-1216-2019 | — | terminated | If cables are improperly connected, current may reach high charge density, causing tissue harm. |