Indianapolis, IN, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QFX | Diagnostic Neurosurgical Microscope Filter | Class II | Neurology | 1 | 2024-03-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-04-30 | Class II | Terminated | Z-1840-2021 | Myriad-LX Light Source-for delivery of light to the surgical field to enhance visualization of tissue during resection … | — | (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical… |
| 2021-04-30 | Class II | Terminated | Z-1839-2021 | NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. 11ga REF: NN-1001 Mvriad-LX Illumination P… | — | (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal opening of the delivery sleeve and tissue/debris within the surgical… |