DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Scooter (Model: FDB01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ABLE CENTRAL VENOUS CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 Direct

FDA 510(k)

FDA Class 2 ·Microbiology

IPULSE, MODEL I400

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPULSE HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmoothSkin BARE+

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDART DIODE LASER SYSTEM & ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Fine Structure Analysis(fineSA)

FDA 510(k)

FDA Class 2 ·Radiology