Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MODEL EC9-4 TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON CV70 CARDIOVASCULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON X150 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\

FDA 510(k)

FDA Class 1 ·General Hospital

PATIENT EXAMINATION GLOVES (VINYL)

FDA 510(k)

FDA Class 1 ·General Hospital

MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON P50 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON ACUNAV 8F ULTRASOUND CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FOURSIGHT VIEWTOOL IMAGE VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

HUMAN TUBAL FLUID

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUSON SEQUOIA ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery