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Catalogue (356)
Page 6 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Power cable | Plug Type J | FDA UDI | Class II | Active |
| Autoclavable Drive | Autoclavable Drive | FDA UDI | Class II | Active |
| CRW Non-XY frame Mechanical Set KIT | CRW Non-XY frame Mechanical Set 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 |
| NeuroNav Drive | NeuroNav Drive | FDA UDI | Class II | Active |
| NeuroFortis NeuroSmart Drive HeadStage KIT | NeuroFortis NeuroSmart Drive HeadStage KIT | FDA UDI | Class II | Active |
| NeuroNav Pelican Case | NeuroNav Pelican Case | FDA UDI | Class II | Active |
| Neuro Omega Autoclavable Drive Headstage | Rev. 6.0 | FDA UDI | Class II | Active |
| LeadConfirm | Sterile NeuroSmart/NeuroNav LeadConfirm M_S Cable | FDA UDI | Class II | Active |
| NeuroNav with NeuroFortis Drive Headstage | NeuroNav with NeuroFortis Drive Headstage | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroSmart / NeuroNav LeadConfirm A Cable | NeuroSmart / NeuroNav LeadConfirm A Cable | FDA UDI | Class II | Active |
| Power cable | Plug Type B | FDA UDI | Class II | Active |
| Remote Control | Remote Control | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega Drive Headstage | Neuro Omega with Neuro Omega Drive Headstage | FDA UDI | Class II | Active |
| Neuro Omega Drive Headstage | Neuro Omega Drive Headstage | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | 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 |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Neuro Omega system | Neuro Omega system | FDA UDI | Class II | Active |
| Neuro Omega HS | Neuro Omega HS | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroProbe | NeuroProbe | FDA UDI | Class II | Active |
| NeuroSmart Autoclavable Drive Headstage Kit | Rev. 5 | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots | Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Cannula | Stylet without Cannula | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Power cable | Plug Type M | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega LeadConfirm M Cable | FDA UDI | Class II | Active |
| NeuroNav MER Headstage KIT | NeuroNav MER Headstage KIT | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| NeuroNav Drive Headstage | NeuroNav Drive Headstage | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega LeadConfirm M Adaptor | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Power cable | Plug Type K | 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. |