SMART Bun-Yo-Matic X-Ray

FDA 510(k)

FDA Class 2 ·Radiology

SMART Bun-Yo-Matic CT

FDA 510(k)

FDA Class 2 ·Radiology

CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bonelogic

FDA 510(k)

FDA Class 2 ·Radiology

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)

FDA 510(k)

FDA Class 2 ·Dental

BTC URINE LCG ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HCG ACCU-STICK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SPARROWHAWK DISPOSABLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODULAP LOOP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODULAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODULAP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUALITATIVE ENZYME IMMUNOASSAY-DETECT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTOMATIC TUBING CLAMP SYSTEM (ATC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISUAL BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NORTHO BONE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

UroLift Advanced Tissue Control (ATC) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test

FDA 510(k)

FDA Class 2 ·Microbiology

STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

MODULAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology