Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

FDA 510(k)

FDA Class 2 ·Microbiology

Hemolung Respiratory Assist System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hemospray Endoscopic Hemostat

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PEDIATRIC VISION SCANNER

FDA 510(k)

FDA Class 2 ·Ophthalmic

Accelerate Pheno system, Accelerate Phenotest BC Kit

FDA 510(k)

FDA Class 2 ·Microbiology

MagDI System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SNOO Smart Sleeper

FDA 510(k)

FDA Class 2 ·General Hospital

Banyan BTI

FDA 510(k)

FDA Class 2 ·Immunology

Sepsis ImmunoScore

FDA 510(k)

FDA Class 2 ·General Hospital

Eonis SCID-SMA Kit

FDA 510(k)

FDA Class 2 ·Immunology

FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Retrograde Intubation Set

FDA 510(k)

FDA Class 2 ·Anesthesiology

RIDASCREEN NOROVIRUS 3RD GENERATION EIA

FDA 510(k)

FDA Class 2 ·Microbiology

IDx-DR

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dignitana AB DigniCap System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BioHealx Anal Fistula Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FilmArray Meningitis/Encephalitis(ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Body Temperature Software (BTS)

FDA 510(k)

FDA Class 2 ·General Hospital

AmplideX Fragile X Dx & Carrier Screen Kit

FDA 510(k)

FDA Class 2 ·Immunology

MAMMAPRINT

FDA 510(k)

FDA Class 2 ·Immunology