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

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY AND THE APTIMA HCV RNA QUALITATIVE ASSAY

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)

AquaPulse Auxiliary Water Connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANDORATE® Valve Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AquaPulse Irrigation Tubing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Andorate Biopsy Valve, Andorate Biopsy Irrigator

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Andorate Universal Endoscope Tip Guard

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

andorate Suction Valve, andorate Air/Water Valve

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANDORATE® Valve Kit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AquaPulse® Irrigation Tubing

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GERONIMO

FDA 510(k)

FDA Class 2 ·Physical Medicine

CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

FDA 510(k)

FDA Class 2 ·Orthopedic

FC-700 DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

KOAGULAB* 32-S COAGULATION SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

FDA 510(k)

FDA Class 2 ·Microbiology