35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

FDA 510(k)

FDA Class 2 ·Microbiology

SCULPTOR ROBOTIC GUIDANCE ARM (RGA)

FDA 510(k)

FDA Class 2 ·Neurology

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

PDT-FACE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)

FDA 510(k)

FDA Class 2 ·Radiology

Picosecond Laser System (Model PS10-A and PS10-B)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FENCER 308 EXCIMER LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery