OPTIGEN TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BONGROS HA

FDA 510(k)

FDA Class 2 ·Dental

GLUCODR AUTO SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DYNA LOCKING TROCHANTERIC NAIL, MODEL NG0820

FDA 510(k)

FDA Class 2 ·Orthopedic

nCommand Lite System

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER

AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLAATZ 750E

FDA 510(k)

FDA Class 2 ·Radiology

XGEO GR40CW

FDA 510(k)

FDA Class 2 ·Radiology

PERFIX ILIAC SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SIMPLELINE II ABUTMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

BC PLUS

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

PROPENCIL ESU PENCIL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FM20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312

FDA 510(k)

FDA Class 2 ·Cardiovascular

WELL-PEX

FDA 510(k)

FDA Class 2 ·Dental