TOTAL BILIRUBIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HILAR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)

FDA 510(k)

FDA Class 2 ·Neurology

ASTRA TOTAL PROTEIN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUHEART ELECTRODE BELT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600

FDA 510(k)

FDA Class 2 ·Physical Medicine

Encision AEM Monopolar Laparoscopic Instruments and Accessories

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

INTEGRATED DISPLAY TECHNOLOGY LTD.

FDA 510(k)

FDA Class 2 ·General Hospital

BT-338N ELECTRONIC CLINICAL THERMOMETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry