Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOSTON LENS(R) CLEANER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV ReadyPack Reagents and Quality Control Materials

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·KONTRON CUTANEOUS PCO2 MONITOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·B&L CONCENTRATED CLEANER

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR AMPICILLIN/SULBACTAM

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE AST FOR MOXIFLOXACIN

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000 SYSTEM

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·PLAIN GUT SUTURES

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER, IMAGE CHECKER LICENSE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS CEFOTETAN CARD

Mesh, Surgical, Polymeric

FDA Pre-Market Approval

FDA Class 2 ·FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT