V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS

Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Cyclosporine Radioimmunoassay

FDA Pre-Market Approval

FDA Class 2 ·SANDIMMUNE(R) RADIOIMMUNOASSAY KIT

TERUMO MICRO TAPERED PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDICAL DISPLAY, MD205MG

FDA 510(k)

FDA Class 2 ·Radiology

FDR SE Lite

FDA 510(k)

FDA Class 2 ·Radiology

21.3 INCH MONOCHROME LCD MONITOR

FDA 510(k)

FDA Class 2 ·Radiology

JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital