VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE

FDA 510(k)

FDA Class 2 ·Microbiology

MEC-I-TRON, MODEL P-1

FDA 510(k)

FDA Class 2 ·Neurology

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE VRSA SCREEN

FDA 510(k)

FDA Class 2 ·Microbiology

HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

INFINITY HBA KIT, MODELS 537-A, 537-B

FDA 510(k)

FDA Class 2 ·Hematology

THORA-DRAIN(R) ABT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SMARTDOP 20 BI-DIRECTIONAL BLOOD FLOW DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

STORZ DP4101 BASIC I/A PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED

FDA 510(k)

FDA Class 2 ·Anesthesiology

STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK 2 AST ST MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

VITEK 2 GRAM POSITIVE MEROPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

GLUCOSE(TRINDER) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

FDA 510(k)

FDA Class 2 ·Microbiology

COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408

FDA 510(k)

FDA Class 2 ·Dental