FRAXIS DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASPIRON ACP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STERI-OSS Implant System

FDA 510(k)

FDA Class 2 ·Dental

Velofix™ SA Cervical Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE NORMALINE KIT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE NORMALINE KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·artus CMV RGQ MDx Kit and artus CMV QS_RGQ MDx Kit

BONE-TEMNO/STERNUM-TEMNO

FDA 510(k)

FDA Class 2 ·Unknown

CEP 8 SPECTRUMORANGE DNA PROBE KIT

FDA 510(k)

FDA Class 2 ·Immunology

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONCEIVEX CONCEPTION KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CONCEIVEX LATEX-FREE SEMEN COLLECTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FOCUS TOUCH CONCEPTION SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ANEUVYSION

FDA 510(k)

FDA Class 2 ·Immunology

STERILE SURGICAL DRAPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

FDA 510(k)

FDA Class 2 ·Unknown

DECOLLATING TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BONE MARROW COLLECTION KIT AND STAND

FDA 510(k)

FDA Class 2 ·Unknown

SURGICAL UTILITY DRAPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology