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Catalogue (356)
Page 5 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Power cable | Plug Type D | FDA UDI | Class II | Active |
| NeuroSmart MER Headstage KIT | NeuroSmart MER Headstage KIT | FDA UDI | Class II | Active |
| Remote Control | Remote Control | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroProbe | NeuroProbe | FDA UDI | Class II | Active |
| Cannula | Tapered | FDA UDI | Class II | Active |
| NeuroFortis NeuroSmart Drive HeadStage KIT | NeuroFortis NeuroSmart Drive HeadStage KIT | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 1 channel | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots | Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots | FDA UDI | N/A | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| CRW Non-XY frame Mechanical Set KIT | Long Bengun | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Unknown |
| NeuroNav Drive Headstage Kit | NeuroNav Drive Headstage Kit | FDA UDI | Class II | Active |
| NeuroProbe | Non-Shielded | FDA UDI | Class II | Active |
| NeuroSmart Autoclavable Drive Headstage KIT | NeuroSmart Autoclavable Drive Headstage KIT | FDA UDI | Class II | Active |
| Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) | Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 5 channels MER only | FDA UDI | Class II | Active |
| NeuroNav Headstage cable | Headstage cable | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| Neuro Omega with AutoClavable Drive Headstage (AutoClavable) | Neuro Omega with AutoClavable Drive Headstage (AutoClavable) | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 3 channels | 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 |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot | Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot | FDA UDI | N/A | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| NeuroNav MER Headstage | MER Headstage | 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 |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Ground Kit NN | Ground Kit | FDA UDI | Class II | Active |
| NeuroNav with Autoclavable Drive Headstage | NeuroNav with Autoclavable Drive Headstage | FDA UDI | Class II | Active |
| NeuroNav with NeuroNav Drive Headstage | NeuroNav with NeuroNav Drive Headstage | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis Drive | Neuro Omega with NeuroFortis Drive | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 1 channel MER only | FDA UDI | Class II | Active |
| Power cable | Plug Type H | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega Drive Headstage Kit | Neuro Omega Drive Headstage Kit | FDA UDI | Class II | Active |
| Cannula | Extractor | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroNav main unit | NeuroNav main unit | FDA UDI | Class II | Active |
| Power cable | Plug Type B | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | 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. |