System, Imaging, Pulsed Doppler, Ultrasonic

FDA Pre-Market Approval

FDA Class 2 ·HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD

ORTHODONTIC CERAMIC BRACKET

FDA 510(k)

FDA Class 2 ·Dental

Models 2200DR and 1600DR Digital Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO LINK HEALTH MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERB BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

FDA 510(k)

FDA Class 2 ·Radiology

DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIACHEX BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Geon (S2) Nasal Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELEX ELECTRONIC DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA