Auryon Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled

FDA 510(k)

FDA Class 2 ·Cardiovascular

GELBFISH ENDO-VAC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pantheris System

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA 400 PLUS CYCLOSPORINE

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·COBAS INTEGRA CYCLOSPORINE

Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

FDA classification

FDA Class 2 ·Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment

GT990402 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL GT980201 ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Catheter, Peripheral, Atherectomy

FDA classification

FDA Class 2 ·Catheter, Peripheral, Atherectomy

Analyzer, Body Composition, Exempt

FDA classification

FDA Class 2 ·Analyzer, Body Composition, Exempt