BABYCOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

POCKET BVM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Tixel i (TXLI0001)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED WAVE

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LEAP EXPRESS PLUSS

DRAGON X SPSL4HC, DRAGON X SPSL8HC

FDA 510(k)

FDA Class 2 ·Radiology

Vibrant System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV plus

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert Xpress CoV-2/Flu/RSV 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

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

FDA 510(k)

FDA Class 2 ·Microbiology

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

QiF Blood and Fluid Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

SILK'N FX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Columbus Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular