Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·~RMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·SUNLIGHT OMNISENSE BONE SONOMETER

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ANGIOPLASTY (PTCA) CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NON-PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OXYSEPT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ELIPSE 14,000.014 CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI GRUNTZIG DILACA CATHETER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOSTAR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P RGP (MELAFOCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTHERM SOL.

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) LONG CRUISE (TM) PTCA CATHETER

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS