FreeStyle Libre 2 System, FreeStyle Libre 3 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 3 Continuous Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bigfoot Unity Diabetes Management System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR TOBRAMYCIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ZYME ENZYMATIC CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR GENTAMICIN

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR CHLORAMPHENICOL

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR OFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR TETRACYCLINE

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR VANCOMYCIN

12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)

FDA 510(k)

FDA Class 2 ·Radiology

EMMA 1.5T MRI System

FDA 510(k)

FDA Class 2 ·Radiology

Tube, Tracheostomy (W/Wo Connector)

FDA classification

FDA Class 2 ·Tube, Tracheostomy (W/Wo Connector)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Exactech® Equinoxe® Stemless Humeral Components

FDA 510(k)

FDA Class 2 ·Orthopedic