atlas-fda

FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.

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    FDA 510(k)s, PMAs, recalls & trials, linked: predicate search and review-time stats for AI agents.

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    Технические названия из tools/list. Нужны только разработчикам.

    search_recordsFull-text search across 777k+ FDA 510(k) clearances, device recalls, and registered clinical trials. Returns ranked matches with links.
    find_predicatesList predicate device candidates for a 510(k) submission: recent clearances under an FDA product code, with review times and recall indicators. The starting set for predicate research.
    get_clearanceFull detail for one FDA 510(k) clearance by K-number, including recalls that reference it.
    product_code_statsFDA review-time statistics (median and 90th percentile days to decision), clearance count and recall count for a product code.
    ai_devicesFDA's official Artificial Intelligence-Enabled Medical Devices list (1,500+ authorizations), tracked weekly by Atlas. List recent AI device authorizations, filter by panel or year, or check whether a specific submission number is on the list. openFDA itself has no AI field - this is the joined, queryable version.
    search_recallsSearch FDA device recalls by product code, recalling firm, or free text. Returns recall details with links - use to vet a predicate candidate or monitor a market.
    get_changesNew FDA clearances and recalls since a date - the monitoring feed. Use for 'what changed this week' questions.