Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·MENICON SF-P (TM)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·THE BOSTON TM CLEANER II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ASSAY

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

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

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 2 ·TOTAL PSA MICROTITER ELISA

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·EDAP LT.02 SHOCK WAVE LITHOTRIPTER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·MENICON SUPER EX CONTACT LENS

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, NYLON

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·EDAP LT.01 SHOCK WAVE LITHOTRIPTER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACKS

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

FDA Pre-Market Approval

FDA Class 2 ·ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK