MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology

Transpara (2.1.0)

FDA 510(k)

FDA Class 2 ·Radiology

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

Us2.v2

FDA 510(k)

FDA Class 2 ·Radiology

Us2.ca

FDA 510(k)

FDA Class 2 ·Cardiovascular

Us2.v1

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA/PERFUSION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cliniview

FDA 510(k)

FDA Class 2 ·Radiology

QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307

FDA 510(k)

FDA Class 2 ·Immunology