AEROSOL ONE, NEBULIZER PUMP

FDA 510(k)

FDA Class 2 ·Anesthesiology

DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Stela Automix System

FDA 510(k)

FDA Class 2 ·Dental

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BlueCheck™ Caries Detection & Monitoring

FDA 510(k)

FDA Class 2 ·Dental

ACCUSONIC ADVANTAGE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Mano and Mano Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TRACE TRANSFERRIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

Akunah REFLECT

FDA 510(k)

FDA Class 2 ·Radiology

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALICIA MENSTRUAL CUP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

TISSUE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

E.N.S.I. RETRACTABLE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

SYDNEY IVF EMBRYO BIOPSY MEDIUM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Seer Home

FDA 510(k)

FDA Class 2 ·Neurology

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THE ORTHOTRAINER

FDA 510(k)

FDA Class 1 ·Dental