everlinQ endoAVF System

FDA 510(k)

FDA Class 2 ·Cardiovascular

OraQuick Ebola Rapid Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

GAMMA PI BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

P1 BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

Alinity m BKV

FDA 510(k)

FDA Class 2 ·Microbiology

LEWIS BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

GAMMA LEWIS BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Smith & Nephew Tablet Application

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BLOOD GROUP SUBSTANCE A

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD GROUP SUBSTANCE A,B

FDA 510(k)

FDA Class 2 ·Hematology

BLOOD GROUP SUBSTANCE B

FDA 510(k)

FDA Class 2 ·Hematology

First To Know Syphilis Test

FDA 510(k)

FDA Class 2 ·Microbiology

Lenire Tinnitus Treatment Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

P1 BLOOD GROUP SUBSTANCE

FDA 510(k)

FDA Class 2 ·Hematology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE NEEDLE DESTROYER

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·SHARP(X)TM NEEDLE DESTRUCTION UNIT