ACQA

FDA 510(k)

FDA Class 2 ·Radiology

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

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FORA G90 PERFORM BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lifetech Cardio Model 8301 Temporary Pacemaker

FDA 510(k)

FDA Class 2 ·Cardiovascular

Enteral Pump Syringe

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118

FDA 510(k)

FDA Class 2 ·General Hospital

Syringe with safety needle, Safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Intelligence LaserComb

FDA 510(k)

FDA Class 2 ·Physical Medicine

VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Natural rubber latex male condom

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VR MEDICAL ENTERAL ORAL SYRINGE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Electric breast pump (model: M5)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DA01 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry