NOVEL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ATLAS IMPLANT SYSTEM- MINI PLUS

FDA 510(k)

FDA Class 2 ·Dental

UniSpace® Stand-Alone C Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

POLYBONE GRANULE & BLOCK

FDA 510(k)

FDA Class 2 ·Orthopedic

Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LUBREASE FEMALE LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ViaOne Epicardial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

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

ANTIGEN CONTROL CELLS

FDA 510(k)

FDA Class 2 ·Microbiology

RUBAZYME

FDA 510(k)

FDA Class 2 ·Microbiology

RUBELLA ANTIBODY FLUOROIMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

TEST FOR DETECTION OF ANTIRUBELLA ANTIB

FDA 510(k)

FDA Class 2 ·Microbiology

ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)

FDA 510(k)

FDA Class 2 ·Microbiology

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD

FDA 510(k)

FDA Class 2 ·Microbiology

RUBELLA BIO-BEAD TITRATION KIT

FDA 510(k)

FDA Class 2 ·Microbiology

CORDIA R

FDA 510(k)

FDA Class 2 ·Microbiology