Devices
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Premarket Approval (PMA) is the most stringent type of device marketing application required by Food and Drug Administration (FDA). The applicant must receive FDA approval of its P...
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FDA Recognized Consensus Standards database includes standards recognized by FDA and used to make an appropriate decision regarding the clearance or approval of a submission. Infor...
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The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. The regula...
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This data package contains the access to Humanitarian Device Exemption provided by the FDA for Humanitarian Use Device (HUD). Humanitarian Use Device (HUD) is a device that is in...
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This dataset is one of the surveys carried out by Dartmouth Atlas under the umbrella "Effective Care". Effective care refers to services that are of proven value and have no signif...
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This data package contains the lists of manufacturer and user facility device experience database data which represents Reports of adverse Events involving medical Devices the dat...
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Manufacturer and User Facility Device Experience Database represents Reports of adverse Events involving medical Devices. The dataset contains 75 fields including a MDR Report ke...
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Manufacturer and User Facility Device Experience Database represents Reports of adverse Events involving medical Devices. The dataset contains 6 fields including an MDR Report ke...
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Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to mo...
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Medical Device Establishment Contact Addresses dataset contains address details of medical device establishments including full address and postal codes listed by Adress ID. Initia...