To celebrate 35 years of FDA approved heart valves and to help our clients and partners learn from previous evaluations, we've compiled a list of 24 approved valves from FDA data, including summaries of their safety and effectiveness from the FDA website. Please provide your name, company name and email address to get your copy today.
U.S. Food and Drug Administration
Office of Device Evaluation (ODE)
Office of Combination Products
Office of Orphan Products Development
CDRH Device Advice
ASTM International (originally American Society for Testing and Materials)
International Organization for Standardization
CE Marking Medical Devices
American National Standards Institute (ANSI)
Association for the Advancement of Medical Instrumentation
Clinical and Laboratory Standards Institute
The American Association for Thoracic Surgery (AATS)
The American College of Cardiology (ACC)
The American Heart Association (AHA)
The American Society of Mechanical Engineers (ASME-BED)
The Biomedical Engineering Society (BMES)
The Heart Valve Society
The Heart Valve Society of America
The Society of Thoracic Surgeons
Society for Biomaterials
Transcatheter Cardiovascular Therapeutics (TCT)
Trancatheter Valve Therapies
Bridgemed Solutions, Inc.
United Biologics Inc.
Wake Forest Innovations Preclinical Translational Services
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Answer a few questions about our website and we'll enter you into draw for a limited edition KENEK EDGE Pulse Oximeter.
Prizes will be shipped to 5 North American survey respondents that include their email contact information.