MMAC II TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

MALLARD AIR OXYGEN ACCUBLENDER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROCARE PLUS VITRECTOMY SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORTHOPLUG SOFT BONE DESIGN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VIT CUTTER MODEL 94

FDA 510(k)

FDA Class 2 ·Ophthalmic

NEO-MED DLS-1100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I/A VITROPHAGE MODEL YPR 2001

FDA 510(k)

FDA Class 2 ·Ophthalmic

BAYERS BIMANUAL I/A HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ORTHOPLUG HARD BONE DESIGN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA TEST KIT

Analyzer, Medical Image

FDA Pre-Market Approval

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-EIA DIAGNOSTIC TEST KIT

Analyzer, Medical Image

FDA Pre-Market Approval

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

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT AXSYM CEA (LIST 7A47)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·OPUS(R) CEA TEST SYSTEM

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX-CEA (LIST 3A33)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA--RIA DIXGNOSTIC TEST KIT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY