Company ยท AU
Genea Biomedx Pty, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2018. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 7, 2018 | K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| Apr 20, 2018 | K180304 | Geri Embryo Incubator and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| Nov 15, 2017 | K171736 | Geri Embryo Incubator and Geri Dish Genea Biomedx Pty, Ltd., AU | MQG |
| Sep 28, 2017 | K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 Genea Biomedx Pty, Ltd., AU | MQL |
| May 24, 2017 | K162409 | Gems Vitrification Set, Gems Warming Set Genea Biomedx Pty, Ltd., AU | MQL |
| May 12, 2017 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase Genea Biomedx Pty, Ltd., AU | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||