FDA 510(k) Device Clearance Landscape Report

Search the FDA's database of **55,000+ Premarket Approval (PMA) records** for Class III medical devices — the most stringent pathway for high-risk devices like implantable defibrillators, heart valves, hip implants, and cochlear implants.

Track drug candidates through clinical trial phases. One tool call for AI agent pharmaceutical competitive intelligence.

FDA 510(k) Device Clearance Search

ryanclinton/fda-510k-clearances

Search the FDA's database of **174,000+ 510(k) premarket notification clearances** for medical devices. Filter by device name, company, product code, advisory committee, decision type, clearance type, date range, or country.

openFDA 510(k) Device Clearances Scraper

automation-lab/openfda-510k-device-clearances-scraper

Export FDA 510(k) medical device clearance records by applicant, product code, k-number, decision date, and clearance metadata.

FDA Recalls Scraper: Drug, Device & Food Alert Monitor

themineworks/fda-recalls-scraper

Scrape FDA drug, device & food recall and enforcement reports as clean JSON. Filter by classification, status, firm, state & date. Free tier, no API key. Works in Claude, ChatGPT & any MCP agent.

MCP server exposing FDA, CDC, NIH, PubMed and clinical-trials data as 15 agent tools. Connect Claude, Cursor, n8n or the OpenAI Agents SDK. Not medical advice.

Query FDA MAUDE adverse events, 510(k) clearances, and device recalls. One tool call for AI agent medical device compliance research.

Fda Intelligence Mcp

ryanclinton/fda-intelligence-mcp

Fda Intelligence Mcp. Available on the Apify Store with pay-per-event pricing.

Clinical Trials & FDA Pipeline Intelligence Scraper

constructive_calm/clinical-trials-fda-scraper

Unified clinical-trial + FDA intelligence: trial search, drug approvals, 510(k) and PMA device clearances, adverse events, recalls, drug shortages, and a sponsor-pipeline rollup. Built on official ClinicalTrials.gov v2 + OpenFDA APIs. Zero anti-bot. Optional Gemini AI summaries.

FDA 510(k) Competitor Clearance Tracker

zentrafoundry/fda-510k-competitor-clearance-tracker

Monitor manufacturers, product codes, decision windows, and advisory committees for new FDA 510(k) clearances and competitor movement.

FDA Product Intelligence — Approvals & Recalls

ryanclinton/fda-product-intelligence

Get a comprehensive FDA regulatory intelligence report for any drug, device, or food product — combining approvals, adverse events, and recalls from **9 openFDA endpoints** in a single run.