Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MODEL4553 MICRO-PACE,DUAL-CHAMBER,DDD TEMPORARY CARDIAC PACEMAKER

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 NOVA

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 ADVANCED EXPERT SYSTEM SOFTWARE

Suture, Nonabsorbable, Silk

FDA Pre-Market Approval

FDA Class 2 ·NONABSORBABLE SURG. SUTURES, BRAIDED SILK

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 2000

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST PANEL FOR STREPTOCOCCUS PNEUMONIAE: TRIMETHOPRIM/SULFAMETHOXAZOLE

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TECHNOMED INTERNATIONAL SONOLITH 2000

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Atellica IM Analyzer Hepatitis C (aHCV)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AZTRENAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER