FDA Medical Device Clearances: 510(k) & PMA Approvals (openFDA)

FDA Medical Device Recall Search

ryanclinton/fda-device-recalls

FDA Medical Device Recall Search queries the U.S. Food and Drug Administration's openFDA device enforcement endpoint to retrieve detailed, structured data about medical device recalls.

FDA 510(k) Scraper - Medical Device Clearance API

pink_comic/fda-510k-medical-device-clearances

Search FDA 510(k) medical device clearances via the official OpenFDA API. Use this scraper/API to find cleared devices by name, applicant, product code, or decision date and monitor competitor approvals, regulatory decisions, and predicate devices. No FDA API key needed.

FDA 510(k) Clearances Scraper | 11 Fields, No API Key

themineworks/fda-510k-device-clearances

Scrape FDA 510(k) medical device clearances by company, device, or product code. Returns applicant, decision date, decision type & panel for medtech competitive intel and regulatory affairs. No API key. Use it as an MCP server in Claude, ChatGPT & AI agents.

Scrape EU-registered medical devices from EUDAMED (2.6M+). Device, risk class, status, manufacturer & EU authorised representative. MDR/IVDR compliance & medtech leads. Free, no key, no proxy.

FDA 510(k) Device Clearances Scraper

nexgenwatch/fda-510k-device-clearances

Clean, structured records of medical-device 510(k) clearances, sourced live from the official openFDA device 510(k) API (https://api.fda.gov/device/510k.json) — an anonymous, documented U.S. Food & Drug Administration endpoint.

Search clinical trials authorised in the EU/EEA from the public CTIS portal (EMA): trial number, title, conditions, products, phase, sponsor, countries and sites, enrolment, endpoints and decision dates. Filter by topic.

Search FDA MAUDE (Manufacturer and User Facility Device Experience) adverse event reports for medical devices. Report numbers, device names, manufacturer names, event types, dates, patient outcomes, and product problems. Official openFDA data, no API key.

FDA 510(k) Clearances Scraper — Device Approvals

devilscrapes/fda-510k-clearances-scraper

Export openFDA 510(k) premarket device clearance records — applicant, device name, decision date and code, product code, advisory committee, device class and regulation number — filterable by applicant, device, product code, committee, class or decision-date range, as clean JSON, CSV or Excel.

Search FDA medical device registrations — 510(k) clearances, PMA approvals, device classifications. Medtech intelligence, regulatory compliance, competitive analysis.

Scrapes FDA's official Section 506J medical device shortage list and device discontinuance list into structured records.