Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT ACCUDETECT 6.1.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PARASCRIPT (R) ACCUDETECT (R)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHAMPION WRAP PTCA CATHETER

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C TEST SERVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·Logicon Caries Detection Software

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·MICROVEL(R) WITH HEMASHIELD

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

FDA Pre-Market Approval

FDA Class 2 ·HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES