SYNTHES ACIS/VERTEBRAL SPACER CR

FDA 510(k)

FDA Class 2 ·Orthopedic

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)

FDA 510(k)

FDA Class 2 ·Hematology

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

ACI SINGLE LUMEN BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

ACI FINE NEEDLE ASPIRATION BIOPSY KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

6% ORTHO LOLIUDINE REAGENT IN GLACID ACI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology