4,855 results · 38ms · Sources: EU EUDAMED, US FDA

SYSTEMATE CALCIUM (EPOS APPLICATION) #65409

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NICHOLS APO B CHEMILUMINESCENCE ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

EPO-TRAC BY RADIOIMMUNOASSAY (RIA)

FDA 510(k)
FDA Class 2 ·Hematology

BD MAX Check-Points CPO

FDA 510(k)
FDA Class 2 ·Microbiology

SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

APO A-1 CHEMILUMINESCENCE ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADVIA Centaur Erythropoietin (EPO) assay

FDA 510(k)
FDA Class 2 ·Hematology

SYSTEMATE CREATININE (EPOS APPLICATION) #65413

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYSTEMATE GGT (EPOS APPLICATION) #65414

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

I-GLASSES LTD.

FDA registration
I-GLASSES LTD.·1 product·🇭🇰 Hong Kong

TRINITY OPTICAL MANUFACTORY LTD

FDA registration
TRINITY OPTICAL MANUFACTORY LTD·1 product·🇭🇰 Hong Kong

I-GLASSES LTD.

FDA registration
I-GLASSES LTD.·1 product·🇭🇰 Hong Kong

Dexcam3

FDA registration
WINUS TECHNOLOGY CO., LTD.·1 product·🇰🇷 South Korea

TRINITY OPTICAL MANUFACTORY LTD

FDA registration
TRINITY OPTICAL MANUFACTORY LTD·1 product·🇭🇰 Hong Kong

Medical Goggles

FDA registration
I-GLASSES LTD.·1 product·🇭🇰 Hong Kong

TRINITY OPTICAL MANUFACTORY LTD

FDA registration
TRINITY OPTICAL MANUFACTORY LTD·1 product·🇭🇰 Hong Kong

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval
FDA Class 3 ·APLIGRAF

Flow Sensor

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Besmed Health Business Corp.·1 device