Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·CMW ORTHOPEDIC BONE CEMENT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THIMEROSAL PRESERVED SALINE SOLUTION

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION(TM) UV (VASURFILCON)

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NOVAFIL(TM)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·VISTAMARC TORIC (ETAFILCON A)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENSOAK

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILATATION CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE DS FFDM SYSTEM

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·9YDRON HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT ANTI-HCV

Accessories, Solution, Ultrasonic Cleaners For Lenses

FDA Pre-Market Approval

FDA Class 2 ·UNIZYME(TM) ENZYMATIC CLEANER

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·PERI-OSS