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Catalogue (356)
Page 4 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| LeadConfirm | Sterile NeuroSmart/NeuroNav MER LeadConfirm M_S Cable | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 2 channels | FDA UDI | Class II | Active |
| NeuroNav Headstage cable - Autoclavable | Headstage cable - Autoclavable | FDA UDI | Class II | Active |
| Starfix frame Mechanical Set Kit | Starfix frame Mechanical Set KIT | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 3 channels MER only | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 4 channels | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| LeadConfirm | Sterile LeadConfirm M_S Cable | FDA UDI | Class II | Active |
| HaGuide Software | HaGuide Software | FDA UDI | Class II | Active |
| NeuroProbe | NeuroProbe | FDA UDI | Class II | Active |
| Leksell Non-XY frame Mechanical Set KIT | Long Bengun | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 2 channels MER only | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega LeadConfirm B Cable | FDA UDI | Class II | Active |
| Libenger RM frame Mechanical Set KIT | Libenger RM frame Mechanical Set KIT | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot | Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot | FDA UDI | Class II | Active |
| Cannula | Insertion Tube Set 15mm above | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 5 channels MER only | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis Drive Headstage | Neuro Omega with NeuroFortis Drive Headstage | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Libenger ZD frame Mechanical Set Kit | Libenger ZD frame Mechanical Set KIT | FDA UDI | Class II | Active |
| Power cable | Plug Type I | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega Drive Headstage | Neuro Omega with Neuro Omega Drive Headstage | FDA UDI | Class II | Active |
| NeuroNav with Autoclavable Drive Headstage | Rev. 5 | FDA UDI | Class II | Active |
| Neuro Omega LeadConfirm P Cable | Neuro Omega LeadConfirm P Cable | FDA UDI | Class II | Active |
| NeuroFortis NeuroSmart Drive Headstage KIT | NeuroFortis NeuroSmart Drive Headstage KIT | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 2 channels | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroSmart MER HeadStage KIT | NeuroSmart MER HeadStage KIT | FDA UDI | Class II | Active |
| Neuro Omega MER Headstage | Neuro Omega MER Headstage | FDA UDI | Class II | Active |
| Leibinger RM frame Mechanical Set KIT | Long Bengun | FDA UDI | Class II | Active |
| Cannula | Insertion Tube Set 15mm above | FDA UDI | Class II | Active |
| NeuroNav MER HeadStage KIT | NeuroNav MER HeadStage KIT | FDA UDI | Class II | Active |
| NeuroOmega System | Neuro Omega System | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Neuro Omega Autoclavable Drive Headstage KIT | Neuro Omega Autoclavable Drive Headstage KIT | FDA UDI | Class II | Active |
| Neuro Omega ECOG HeadBox Kit | Neuro Omega ECOG HeadBox Kit | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 4 channels | FDA UDI | Class II | Active |
| LeadConfirm | Sterile Neuro Omega MER LeadConfirm M_S Cable | FDA UDI | Class II | Active |
| Cannula | Array electrode insertion tube | FDA UDI | Class II | Active |
| NeuroSmart with AutoClavable Drive Headstage (AutoClavable) | NeuroSmart with AutoClavable Drive Headstage (AutoClavable) | 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. |