LOOK VISCODISSECTOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

PLAIN AND CHROMIC GUT SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SILK SUTURES-REVISED LABELING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOTAL SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DVTCARE CA5

FDA 510(k)

FDA Class 2 ·Cardiovascular

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D

da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology