MULTI-MODALITY IMAGE FUSION

FDA 510(k)

FDA Class 2 ·Radiology

COMPASS COMPRESSION ASSIST HANDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

EQUIPMENT/MATERIAL DECONTAMINATING KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Personalized Physiology Analytics Engine software

FDA 510(k)

FDA Class 2 ·Cardiovascular

UltraEzAir® (UEA1A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Alio Medical Remote Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CROWN & BRIDGE RESIN FOR FABRICAT/DE

FDA 510(k)

FDA Class 2 ·Dental

Kuvia3D

FDA 510(k)

FDA Class 2 ·Radiology

EPIFLO-28

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CROWN S BRIDGE RESIN

FDA 510(k)

FDA Class 2 ·Dental

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs Immunoassay

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE 2000 Anti-HBs

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBs II

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc II

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Elecsys Anti-HBc IgM