ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

Gem Flow Now (GEM2770-FN)

FDA 510(k)

FDA Class 2 ·Radiology

KENDALL CO2NFIRM NOW CO2 DETECTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

FDA 510(k)

FDA Class 2 ·Microbiology

SODIUM CHLORIDE SOLUTION BLOOD CELL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MICROMAT W/VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRION Embolic Protection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCath XC Peripheral Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViperCross Support Catheters

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular