Company
Oculus Optikgeraete GMBH
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MXK | Device, Analysis, Anterior Segment | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Myopia Master , Ref 68100, CE 0123 Open, Classified |
MXK | K202989 |
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL , Ref 70100, CE 0123 Open, Classified |
MXK | K152311 |
| Aug 30, 2023 | Oculus Optikgeraete GMBH Oculus Pentacam AXL Wave, Ref 70020, CE 0123 Open, Classified |
MXK | K201724 |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam HR REF 70900. Used to image the anterior segment of the eye. Open, Classified |
MXK | K030719 |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam AXL REF 70100,
Pentacam HR REF 70900. Used to image the anterior segment of the eye. Open, Classified |
MXK | K152311 |
| Jul 8, 2022 | Oculus Optikgeraete GMBH Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Open, Classified |
MXK | K201724 |
| Nov 21, 2017 | Oculus Optikgeraete GMBH OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany.
The Pentacam AXL is designed to ta Terminated |
MXK | K152311 |