PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

BIOPSY PIPETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SATURN 5 LASER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

MONOLISA ANTI-HAV EIA

FDA 510(k)

FDA Class 2 ·Microbiology

MONOLISA ANTI-HAV IGM EIA

FDA 510(k)

FDA Class 2 ·Microbiology

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

S57D DIGITAL OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 67D OPERATING ROOM CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-57 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-52 ELECTRONIC VIDEO LAPAROSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO LIGHT SOURCES AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-357 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 61D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

T.B.R. ZIRCONNECT

FDA 510(k)

FDA Class 2 ·Dental

TBR IDEA CONIC/CONIC

FDA 510(k)

FDA Class 2 ·Dental