FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DuraGraft

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology

Active Anthrax DetectTM Plus Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

simpli-COLLECT STI Test

FDA 510(k)

FDA Class 2 ·Microbiology

The SensiTox B. anthracis Toxin Test

FDA 510(k)

FDA Class 2 ·Microbiology

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

Nano-Check™ COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

Diode laser device (RF3120-BI)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery