Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Genea Biomedx Pty, Ltd.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2018-06-07
TypeNumberDevice NameCodeDateActions
510(k) K180188 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG2018-06-07 View
510(k) K180304 Geri Embryo Incubator and Geri DishMQG2018-04-20 View
510(k) K171736 Geri Embryo Incubator and Geri DishMQG2017-11-15 View
510(k) K170498 Gems Oocyte Retrieval Buffer ORB-20, ORB-50MQL2017-09-28 View
510(k) K162409 Gems Vitrification Set, Gems Warming SetMQL2017-05-24 View
510(k) K161261 Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBaseMQL2017-05-12 View