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Catalogue (356)
Page 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 2 channels MER only | FDA UDI | Class II | Active |
| Power cable | Plug Type M | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| NeuroSmart with NeuroFortis Drive | NeuroSmart with NeuroFortis Drive | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Power cable | Plug Type F | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| NeuroNav with NeuroFortis Drive | NeuroNav with NeuroFortis Drive | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Power cable | Plug Type D | FDA UDI | Class II | Active |
| NeuroSmart / NeuroNav LeadConfirm P Cable | NeuroSmart / NeuroNav LeadConfirm P Cable | 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 |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Lead Insertion Tube | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Stylet | FDA UDI | Class II | Active |
| Sterile electrode's cable | Sterile electrode's cable | FDA UDI | Class II | Active |
| Neuro Omega EMG HeadBox Kit | Neuro Omega EMG HeadBox Kit | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroProbe | MF-Non-Shielded | FDA UDI | Class II | Active |
| Cannula | Tapered | FDA UDI | Class II | Active |
| NeuroNav Drive Headstage | NeuroNav Drive Headstage | FDA UDI | Class II | Active |
| Neuro Omega Input Cable | 3 channels | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Standard | FDA UDI | Class II | Active |
| Sterile LeadConfirm | Sterile LeadConfirm | FDA UDI | Class II | Active |
| Cannula | Tapered | FDA UDI | Class II | Active |
| Power cable | Plug Type K | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| NeuroNav Input Cable | 1 channel | FDA UDI | Class II | Active |
| NeuroProbe | Non-shielded | FDA UDI | Class II | Active |
| Remote Control | Remote Control | FDA UDI | Class II | Active |
| NeuroProbe | Shielded | FDA UDI | Class II | Active |
| NeuroNav Pelican Case | 1 | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | 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 |
| Bengun W/O Screws | Bengun W/O Screws | FDA UDI | Class II | Active |
| Power cable | Plug Type N-4 mm | FDA UDI | Class II | Active |
| Power cable | Plug Type L-4mm | FDA UDI | Class II | Active |
| NeuroProbe | MF-Shielded | FDA UDI | Class II | Active |
| Cannula | Standard Without Styler | FDA UDI | Class II | Active |
| Cannula | insertion tube Array electrode | 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. |