AZE VIRTUALPLACE

FDA 510(k)

FDA Class 2 ·Radiology

AZE PHOENIX SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Ezee Retrieval

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LENS-EZE

FDA 510(k)

FDA Class 2 ·Ophthalmic

EZEE RETRIEVAL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EZE SIT Valvulotome

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZEE FILTER/SEPARATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NR Line Implant System

FDA 510(k)

FDA Class 2 ·Dental

SuperLine

FDA 510(k)

FDA Class 2 ·Dental

EXERCISER, AIR-EZE INCENTIVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ARTICUL/EZE Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

ARTICUL/EZE FEMORAL HEADS

FDA 510(k)

FDA Class 2 ·Orthopedic

PQ1

FDA 510(k)

FDA Class 2 ·Dental

ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur Enhanced Liver Fibrosis (ELF)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MDI MII ONE-PIECE IMPLANT, 2.9MM

FDA 510(k)

FDA Class 2 ·Dental

CLINICAL ALERT NOTIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular