Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX COMET(TM) CORONARY DILATION CATHETER

Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

FDA Pre-Market Approval

FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

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

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·ABSORBABLE SURGICAL SUTURE, USP

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS

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 ·IGEL 67 CONTACT LENS

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE IBOT 3000/4000 MOBILITY SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS RX STREAK & ACS FLOW TRACK 40

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNETOM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·NATUREVUE CONTACT LENSE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

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 A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER