I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System

FDA 510(k)

FDA Class 2 ·Neurology

FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC

FDA 510(k)

FDA Class 2 ·Ophthalmic

I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL

FDA 510(k)

FDA Class 2 ·Neurology

DRY LASER IMAGER, MODEL DRYPRO MODEL 793

FDA 510(k)

FDA Class 2 ·Radiology

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

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