Genea Biomedx Pty, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish, Geri Embryo Incubator and Geri Dish
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genea Biomedx Pty, Ltd. Obstetrics & Gynecology ✕
6 devices
Cleared
Jun 07, 2018
Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
Obstetrics & Gynecology
135d
Cleared
Apr 20, 2018
Geri Embryo Incubator and Geri Dish
Obstetrics & Gynecology
77d
Cleared
Nov 15, 2017
Geri Embryo Incubator and Geri Dish
Obstetrics & Gynecology
156d
Cleared
Sep 28, 2017
Gems Oocyte Retrieval Buffer ORB-20, ORB-50
Obstetrics & Gynecology
223d
Cleared
May 24, 2017
Gems Vitrification Set, Gems Warming Set
Obstetrics & Gynecology
268d
Cleared
May 12, 2017
Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems...
Obstetrics & Gynecology
373d