Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED ACE(TM)&LONG ACE(TM)PTCA CATHETERS

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·SILK SUTURES

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·TANDEM(R)-E AFP

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTMATE SOLUTION

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 ·USCI GRUNTZIG DILACA CATHETER

Suture, Nonabsorbable, Synthetic, Polyester

FDA Pre-Market Approval

FDA Class 2 ·NON-ABSORBABLE (POLYESTER FIBER) SUTURES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON B) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODELS P15-020,15-025,15-030,15-035, & P15-040

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·THE INTREPID(TM) PTCA CATHETER

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PRESERVED SOFT MATE(R) CONSEPT(R)2 NEUT.& RINS SOL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI APOLLO RELY OVER-THE-WIRE BALLON DILATATION CATHETER WITH HYDRO/PEL COATING AND MINIQUET DEVICE

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY