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

LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ISOLATE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VITRIFREEZE MEDIUM; VITRITHAW MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HSA-SOLUTION, MODEL 10034/10064

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

10% PVP; 10% PVP IN EBSS SOLUTION

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HUMAN SERUM ALBUMIN

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ISM1+, IMS2+, AND UTM+

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology