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Catalogue (356)
Page 7 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroNav | NeuroNav | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroSmart Main Unit | NeuroSmart Main Unit | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroSmart MER Headstage | NeuroSmart MER Headstage | FDA UDI | Class II | Active |
| NeuroProbe | 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 |
| NeuroOmega Autoclavable | Drive | FDA UDI | Class II | Active |
| Power cable | Plug Type L-5.5mm | FDA UDI | Class II | Active |
| Leibinger ZD frame Mechanical Set KIT | Long Bengun | FDA UDI | Class II | Active |
| Neuro Omega NeuroFortis Drive Headstage | Neuro Omega NeuroFortis Drive Headstage | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Tube | Lead Insertion | FDA UDI | Class II | Active |
| LeadConfirm | Sterile NeuroSmart/NeuroNav MER LeadConfirm M Cable | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 4 channels MER only | FDA UDI | Class II | Active |
| NeuroNav with MER Headstage | NeuroNav with MER Headstage | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Neuro Omega EEG Recording Kit | Neuro Omega EEG Recording Kit | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot | Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot | FDA UDI | Class II | Active |
| Cannula | Tapered | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Neuro Omega EMG HeadBox Kit | Neuro Omega EMG HeadBox Kit | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| LeadConfirm | Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor | FDA UDI | Class II | Active |
| NeuroNav Pelican Case | NeuroNav Pelican Case | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 4 channels MER only | FDA UDI | Class II | Active |
| NeuroNav Drive | NeuroNav Drive | FDA UDI | Class II | Active |
| NeuroOmega Autoclavable | Drive-Head Stage | FDA UDI | Class II | Active |
| NeuroNav MER Headstage | MER Headstage | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot | Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot | FDA UDI | N/A | Active |
| NexDrive Electrode Holder | NexDrive Electrode Holder - Pack of 2 | FDA UDI | Class II | Active |
| Insertion Tube | Set 40mm above | FDA UDI | Class II | Active |
| Power cable | Plug Type H | FDA UDI | Class II | Active |
| Ground Kit NN | Ground Kit NN | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 1 channel MER only | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots | Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots | FDA UDI | N/A | Active |
| NeuroSmart with AutoClavable Drive Headstage | Rev. 5 | FDA UDI | Class II | Active |
| NeuroNav Headstage cable - Autoclavable | Headstage cable - Autoclavable | FDA UDI | Class II | Active |
| NeuroNav with NeuroNav Drive | NeuroNav with NeuroNav Drive | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 5 channels | FDA UDI | Class II | Active |
| Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots | Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots | FDA UDI | Class II | Active |
| NeuroSmart with NeuroFortis Drive | NeuroSmart with NeuroFortis Drive | FDA UDI | Class II | Active |
| Power cable | Plug Type G | FDA UDI | Class II | Active |
| Power cable | Plug Type I | 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. |