Affinity Pixie Oxygenator with Balance Biosurface

FDA registration

Medtronic Mexico S. de R.L. de CV·1 product·🇲🇽 Mexico

Affinity Pixie Oxygenator with Balance Biosurface

FDA registration

MEDTRONIC PERFUSION SYSTEMS·1 product·🇺🇸 United States

Affinity Pixie Oxygenator with Balance Biosurface

FDA registration

MIDWEST STERILIZATION CORP.·1 product·🇺🇸 United States

Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LiteCure, LLC

FDA registration

LiteCure, LLC·1 product·🇺🇸 United States

RESMED PTY LTD.

FDA registration

RESMED PTY LTD.·1 product·🇦🇺 Australia

LITECURE, LLC

FDA registration

LITECURE, LLC·1 product·🇺🇸 United States

ResMed Corp

FDA registration

ResMed Corp·1 product·🇺🇸 United States

LT Technology Limited

FDA registration

LT Technology Limited·1 product·🇨🇳 China

RESMED CORP

FDA registration

RESMED CORP·1 product·🇺🇸 United States

Oxygenator, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Oxygenator, Cardiopulmonary Bypass

Codman Disposable Perforators

FDA registration

Integra LifeSciences Production Corporation·1 product·🇺🇸 United States

PARAGON MEDICAL, INC.

FDA registration

PARAGON MEDICAL, INC.·1 product·🇺🇸 United States

WORLDWIDE SUPPLIES LIMITED

FDA registration

WORLDWIDE SUPPLIES LIMITED·1 product·🇭🇰 Hong Kong

ENVIRO SHARP SOLUTIONS 3

FDA 510(k)

FDA Class 2 ·General Hospital

LITECURE THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Container, Sharps

FDA classification

FDA Class 2 ·Container, Sharps

Lamp, Infrared, Therapeutic Heating

FDA classification

FDA Class 2 ·Lamp, Infrared, Therapeutic Heating