BrachyGel Vaginal Hydrogel Packing System

FDA 510(k)

FDA Class 2 ·Radiology

Vibrant System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OsteoProbe

FDA 510(k)

FDA Class 2 ·Orthopedic

NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

FDA 510(k)

FDA Class 2 ·Neurology

DEKA ARM SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

PGDx elio plasma focus Dx

FDA 510(k)

FDA Class 2 ·Pathology

INNOVANCE VWF Ac

FDA 510(k)

FDA Class 2 ·Hematology

VYSIS AUTOVYSION SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Healgen Rapid Check COVID-19/Flu A&B Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

DreaMed Advisor Pro

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Paige Prostate

FDA 510(k)

FDA Class 2 ·Pathology

EndoRotor Device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SkinPen Precision System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

23andMe Personal Genome Service (PGS) Pharmacogenetic Reports

FDA 510(k)

FDA Class 2 ·Medical Genetics

COAPTIUM Connect with TISSIUM LIGHT

FDA 510(k)

FDA Class 2 ·Neurology

EROS-CLITORAL THERAPY DEVICE (CTD)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

LYRA DIRECT STREP ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER

FDA 510(k)

FDA Class 2 ·General Hospital