Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·SUPRAMID EXTRA SUTURES

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·SUPRAMID EXTRA SUTURES

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

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NAVISTAR RMT; NAVISTAR RMT DS CATHETER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER

Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·SUPRAMID EXTRA SUTURES

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRANSPORTABLE MODEL STS-T LITHOTRIPTER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·8LUOREX (TM) 600 (FLURSILFOCON A)

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter, and Biosense Webster Cables

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN RAPID FLUOROGENIC PANELS

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Alinity m HCV

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 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit