Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface

FDA registration

MEDTRONIC PERFUSION SYSTEMS·3 products·🇺🇸 United States

Affinity Fusion™ Oxygenator with Integrated Arterial Filter Biosurface Reservoir, Blood, Cardiopulmonary Bypass

FDA registration

MIDWEST STERILIZATION CORP.·3 products·🇺🇸 United States

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)

FDA 510(k)

FDA Class 2 ·Cardiovascular

NextStep Retrograde

FDA registration

Arrow Internacional de Chihuahua S.A. de C.V.·1 product·🇲🇽 Mexico

NextStep Retrograde

FDA registration

Teleflex LLC (NADC)·1 product·🇺🇸 United States

NextStep Retrograde

FDA registration

Teleflex LLC (NADC 2)·1 product·🇺🇸 United States

NextStep Retrograde

FDA registration

Arrow International, LLC (subsidiary of Teleflex Incorporated)·1 product·🇺🇸 United States

Chest-CAD

FDA registration

IMAGEN TECHNOLOGIES, INC.·1 product·🇺🇸 United States

NextStep Retrograde

FDA registration

Teleflex Medical LLC·1 product·🇺🇸 United States

Oxygenator, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Oxygenator, Cardiopulmonary Bypass

Boston Scientific Corporation

FDA registration

Boston Scientific Corporation·1 product·🇺🇸 United States

ABCORP

FDA registration

ABCORP·2 products·🇺🇸 United States

STEP-TIP CHRONIC HEMODIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MR ELASTOGRAPHY

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Hemodialysis, Implanted

FDA classification

FDA Class 2 ·Catheter, Hemodialysis, Implanted

System, Nuclear Magnetic Resonance Imaging

FDA classification

FDA Class 2 ·System, Nuclear Magnetic Resonance Imaging