GORE VIABIL Short Wire Biliary Endoprosthesis

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS

FDA 510(k)

FDA Class 2 ·Radiology

BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

COD COMPRESSION OSTEOTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

TIGERVIEW PROFESSIONAL

FDA 510(k)

FDA Class 2 ·Radiology

ECONOLITH E3000, MODEL 3000 (SW-6)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEER-III GLENOID RESURFACING PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

HYBRID FIT TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROSELECTRON V3, MODEL 106.990

FDA 510(k)

FDA Class 2 ·Radiology

BlueStar and BlueStar Rx

FDA 510(k)

FDA Class 2 ·Anesthesiology

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

FDA 510(k)

FDA Class 2 ·General Hospital

CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMZ - DENTAL IMPLANT COMPONENTS

FDA 510(k)

FDA Class 2 ·Dental

DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS

FDA 510(k)

FDA Class 2 ·Dental

FRIOS BONESHIELD

FDA 510(k)

FDA Class 2 ·Dental

AMBER DU

FDA 510(k)

FDA Class 2 ·Radiology

ULTRATHERM (908)

FDA 510(k)

FDA Class 2 ·Physical Medicine

OTI MODULAR SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry