BLASTFREEZE AND BLASTTHAW

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GM501 SpermAir and GM501 SpermActive

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDI-CULT M3 MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SYDNEY IVF EMBRYO BIOPSY MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HTF-HEPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SYDNEY IVF EMBRYO BIOPSY MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BLASTASSIST SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VITRIFICATION KIT & VITRIFICATION WARMING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Sydney IVF Sperm Cryopreservation Buffer

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDIA CULTURE SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENHANCE HTF MEDIUM WITH HEPES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

V-HYADASE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology