OSMED EPI-GUIDE

FDA 510(k)

FDA Class 2 ·Dental

Force Fiber OrthoTape suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DSM Biomedical Calcium Phosphate Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

QUARK SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS

QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RADIUS CORONARY STENT W/DELIVERY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC ACE/TRAPPER/SURPASS/REMEDY PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC MAVERICK 2 PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MAVERICK OTW/RANGER PTCA CATHETERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS CORONARY STENT SYSTEM

DSM Biomedical Calcium Phosphate Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

DSM Biomedical Calcium Phosphate Cement with Microspheres

FDA 510(k)

FDA Class 2 ·Orthopedic

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) P MODEL 1600

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635