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FDA 510(k) clearances, PMA approvals, De Novo classifications, recalls, warning letters, PubMed papers, and ClinicalTrials.gov device trials, auto-linked to glossary terms. Subscribe to any single category by selecting it and copying the RSS link.

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Why no IDE category?

FDA treats Investigational Device Exemption (IDE) submissions as confidential under 21 CFR 812.38, there's no public listing or API. IDE activity only surfaces later via clearances, approvals, or trial registrations, which you'll see in the other categories.