Respiratory devices are used to help breathing. Patients may use respiratory devices at home or in a clinical setting, such as a hospital.
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Oct 5, 2023 · Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. Our ...
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FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products.
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Nov 6, 2023 · Welcome to FDA's information about medical device approvals. The following information is available: Recently Approved Devices that include ...
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Aug 25, 2021 · This page provides answers to frequently asked questions about OTC medical devices, including considerations for manufacturers of OTC devices. Q ...
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Sep 14, 2023 · The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more ...
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Nov 8, 2023 · Answers to frequently asked questions about ventilators during the COVID-19 pandemic.
Jan 4, 2023 · Medical device manufacturers are subject to a range of regulatory controls (i.e., requirements) to ensure that devices are not adulterated or ...
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