GUIDOSS

FDA 510(k)

FDA Class 2 ·Dental

DUR-8, MODELS DUR-8

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SONOLAYER S, SSH-60A/SDS-60A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY

FDA 510(k)

FDA Class 2 ·Anesthesiology

FIXATION DEVICES AND BONE PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIAMED MODELS 600, 900, 960, 964

FDA 510(k)

FDA Class 2 ·Radiology

DIRECTIGEN 1-2-3(TM) HCG TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BruxZir Esthetic

FDA 510(k)

FDA Class 2 ·Dental

NURTURE III

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A

FDA 510(k)

FDA Class 2 ·Radiology

ACS WIRE SHAPER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMG-1, MOTOR NERVE MONITOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

HOLTER PACERCORDER(R)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)

FDA 510(k)

FDA Class 2 ·Dental