Company · FR
DIXI MEDICAL USA
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K260337 | SEEG-Tx® System (STX-SYS-001) Dixi Medical, FR | GXD |
| Nov 18, 2021 | K202087 | DIXI Medical Microdeep Micro-Macro Depth Electrodes Dixi Medical, FR | GZL |
| Oct 2, 2021 | K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) Dixi Medical, FR | GYC |
| Nov 24, 2017 | K170959 | DIXI Medical Microdeep Depth Electrode Dixi Medical, FR | GZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |
| Dec 9, 2021 | DIXI MEDICAL USA The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple plat Terminated |
GZL | K170959 |