Cryopush Cold Compression Device

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT2 Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

FDA 510(k)

FDA Class 2 ·Physical Medicine

VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PowerDot PD-01M

FDA 510(k)

FDA Class 2 ·Physical Medicine

PowerDot PD-01MT

FDA 510(k)

FDA Class 2 ·Physical Medicine

CYTOPREP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Hand-held IPL device (JOVS Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cold Compression Wrap Pro

FDA 510(k)

FDA Class 2 ·Physical Medicine

Hand-held IPL device(JOVS Graphene Hair Removal Device)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1-Step Culture Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Atellica® CH Creatinine_3 (Crea3)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATININE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry