Bone Cement

FDA Pre-Market Approval

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

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·LITHOSTAR

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR CEFAZOLIN

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED PTCA CATHETERS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-CLEAN(TM) LC 1323

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur® HCV assay

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) TRAPPER (TM) PTCA CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·PD1413 WETTING, SOAKING AND DISINFECTING SOLUTION

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY(TM) VAGINAL POUCH

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 - CLEAR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT (METHAFILCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON ULTRA

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Hepatitis C (aHCV)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER CHUBBY(TM) PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRA CARE (TM) NEUTRALIZING TABLET

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) 14K OVER THE WIRE CORONARY BALL.CATH.