The NightBlocks Appliance

FDA 510(k)

FDA Class 2 ·Dental

HEMOPLUS

FDA 510(k)

FDA Class 2 ·Hematology

GALENICA'S DISPOSABLE ANOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIGHTING SOURCE SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOSABLE AMNIOTOME

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

PURITAN FOAM TIP SWAB MODEL 2197

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)

FDA Class 2 ·Immunology

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

CLEARVIEW EXACT II INFLUENZA A & B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR IGM

FDA 510(k)

FDA Class 2 ·Immunology

INTROL CF PANEL I CONTROL, MODEL: G106

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

BILI-MIRROR MODEL BLM-1

FDA 510(k)

FDA Class 2 ·General Hospital