SPIROCARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

EKGCARD SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QRS Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: BPCARD, MODEL Z-7000-0700

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tester, Acoustic, Bone Quality

FDA Pre-Market Approval

FDA Class 3 ·QUS-2 CALCANEAL ULTRASONOMETER

RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

QCS-18-11.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025792·

QCS-14-20.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025716·

QMS Plazomicin Immunoassay Calibrator

FDA UDI

Microgenics Corporation·00884883006973·

QCS-18-20.0-20T

FDA UDI

Izi Medical Products, LLC·00815212024023·

QCS-14-11.0-20T

FDA UDI

Izi Medical Products, LLC·00815212025747·

QMS Plazomicin Immunoassay Control

FDA UDI

Microgenics Corporation·00884883006980·

QCS-20-20.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025785·

QCS-14-11.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025730·

QCS-16-20.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025723·

QCS-18-20.0-10T

FDA UDI

Izi Medical Products, LLC·00815212025754·

QCS-16-20.0-20T

FDA UDI

Izi Medical Products, LLC·00815212025693·

QCS-16-11.0-20T

FDA UDI

Izi Medical Products, LLC·00815212025778·

QCS-18-9.0-10T

FDA UDI

Izi Medical Products, LLC·00815212024030·

QCS-20-11.0-20T

FDA UDI

Izi Medical Products, LLC·00815212025822·