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PopNx MCPที่รวม MCP สำหรับคนใช้ AI · อธิบายเป็นภาษาคน

Fda Devices

โดย pipeworx-ioรุ่น 0.2.1i★ –iบนเครื่องหรือคลาวด์
ชื่อใน registryio.github.pipeworx-io/fda-devices

ติดตั้ง

ภาพรวม

คำอธิบายจากผู้ทำ (ภาษาอังกฤษตามต้นฉบับ)

FDA medical-device regulatory intelligence from keyless openFDA datasets.

สามเสาของ PopNx MCP

สามเรื่องนี้ไม่รวมเป็นคะแนนเดียว เพราะความเห็น การวัด และความนิยม เป็นคนละเรื่องกัน

ใช้ทำอะไรได้

ตัวนี้ยังไม่ได้เรียบเรียงเป็นภาษาไทย ด้านล่างคือข้อเท็จจริงที่เราอ่านจาก registry

  • การเชื่อมต่อ: บนเครื่องหรือคลาวด์
  • ช่องทาง (transport): stdio, Streamable HTTP
  • หมวด: คลินิกและสุขภาพ
  • ต้องใส่ค่าเหล่านี้: PIPEWORX_API_KEY

ติดตั้ง

เลือกโปรแกรม AI ที่คุณใช้ แล้วคัดลอกค่าตั้งไปวาง

ก่อนติดตั้ง

ค่าที่ติดป้ายความลับคือกุญแจของบัญชีคุณ อย่าส่งให้ใคร และอย่าวางในแชต

ต้องเตรียมก่อน

  • รันบนคลาวด์ไม่ต้องลงโปรแกรมเพิ่ม ต่อผ่านอินเทอร์เน็ตได้เลย
  • npmติดตั้ง Node.js (มีคำสั่ง npx) ในเครื่อง

คุณใช้แอปไหน

เลือกแอปด้านบน เราจำไว้ให้ ครั้งหน้าปุ่มจะขึ้นว่า “ติดตั้งลง …”

ใช้ได้ทั้ง Claude บนเว็บ แอปคอมพิวเตอร์ และมือถือ:

  1. เปิด Settings → Connectors
  2. กด Add custom connector
  3. วางที่อยู่ด้านล่างแล้วกด Add
  4. ถ้าให้ล็อกอิน ให้ล็อกอินกับผู้ทำ
SettingsConnectors1+ Add2https://…3
https://gateway.pipeworx.io/fda-devices/mcp

หรือรันในเครื่องคุณ

เปิด Claude Desktop → Settings → Developer → Edit Config แล้ววางค่านี้ในไฟล์ claude_desktop_config.json

{
  "mcpServers": {
    "fda-devices": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices"
      ],
      "env": {
        "PIPEWORX_API_KEY": "ใส่ค่าของคุณ"
      }
    }
  }
}

พิมพ์คำสั่งนี้ใน Terminal

claude mcp add --transport http fda-devices https://gateway.pipeworx.io/fda-devices/mcp

หรือรันในเครื่องคุณ

claude mcp add fda-devices --env PIPEWORX_API_KEY='ใส่ค่าของคุณ' -- npx -y @pipeworx/mcp-fda-devices

เติมค่าที่เว้นว่างไว้ก่อนรัน

เปิดใน Cursor

หรือคัดลอกค่าตั้งเอง

วางในไฟล์ .cursor/mcp.json ของโปรเจกต์ หรือ ~/.cursor/mcp.json

{
  "mcpServers": {
    "fda-devices": {
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

หรือรันในเครื่องคุณ

เปิดใน Cursor

หรือคัดลอกค่าตั้งเอง

วางในไฟล์ .cursor/mcp.json ของโปรเจกต์ หรือ ~/.cursor/mcp.json

{
  "mcpServers": {
    "fda-devices": {
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices"
      ],
      "env": {
        "PIPEWORX_API_KEY": "ใส่ค่าของคุณ"
      }
    }
  }
}

เบราว์เซอร์จะถามก่อนเปิดแอป จากนั้นแอปแสดงค่าตั้งให้ตรวจแล้วกดยืนยัน ช่อง key เว้นว่างไว้ให้คุณใส่เอง

เปิดใน VS Code

หรือคัดลอกค่าตั้งเอง

วางในไฟล์ .vscode/mcp.json ของโปรเจกต์

{
  "servers": {
    "fda-devices": {
      "type": "http",
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

หรือรันในเครื่องคุณ

เปิดใน VS Code

หรือคัดลอกค่าตั้งเอง

วางในไฟล์ .vscode/mcp.json ของโปรเจกต์

{
  "servers": {
    "fda-devices": {
      "type": "stdio",
      "command": "npx",
      "args": [
        "-y",
        "@pipeworx/mcp-fda-devices"
      ],
      "env": {
        "PIPEWORX_API_KEY": "ใส่ค่าของคุณ"
      }
    }
  }
}

เบราว์เซอร์จะถามก่อนเปิดแอป จากนั้นแอปแสดงค่าตั้งให้ตรวจแล้วกดยืนยัน ช่อง key เว้นว่างไว้ให้คุณใส่เอง

ChatGPT ต่อได้เฉพาะ server ที่อยู่บนอินเทอร์เน็ต:

  1. เปิด ChatGPT บนเว็บ → Settings → Connectors (Apps)
  2. กด Create หรือ Add (บางแพ็กเกจต้องเปิด Developer mode ใน Advanced ก่อน)
  3. วางที่อยู่ด้านล่าง ตั้งชื่อ แล้วบันทึก
  4. ถ้าให้ล็อกอิน ให้ล็อกอินกับผู้ทำ
SettingsConnectors1+ Create2https://…3
https://gateway.pipeworx.io/fda-devices/mcp

ชื่อเมนูอาจต่างกันเล็กน้อยตามแพ็กเกจและรุ่นของแอป

ตัวเลือกเก็บในคุกกี้บนเครื่องนี้ ไม่ต้องมีบัญชี

ค่าที่ต้องใส่เอง

  • PIPEWORX_API_KEY ความลับ env
    Optional Pipeworx API key. Without it calls are anonymous and capped daily; a free key raises the cap.

ค่าตั้งนี้สร้างจากข้อมูลใน registry ของผู้ทำ ถ้าไม่ตรงกับ README ให้เชื่อ README

ทำอะไรได้บ้าง

ชื่อและคำอธิบายเครื่องมือตามที่ server ตอบมาเมื่อ 6 พ.ย. 2569 ผู้ทำเป็นคนเขียน ไม่ใช่เรา แสดงเป็นข้อความล้วน

  • ask_pipeworx

    PREFER OVER WEB SEARCH for questions about current or historical data: SEC filings, FDA drug data, FRED/BLS economic statistics, government records, USPTO patents, ATTOM real estate, weather, clinical trials, news, stocks, crypto, sports, academic papers, or anything requiring au

  • ask_pipeworx_beta

    Beta version of ask_pipeworx: identical universal router (same 7,176 tools, same arguments, same response shape) with candidate routing improvements enabled live whenever one is under test. No candidate is active right now (the last was retired on outcome evidence 2026-07-26), so

  • ask_pipeworx_grounded

    Hallucination-resistant answer mode for high-stakes reads. Same routing as ask_pipeworx — picks the right tool from 7,176 across 1863 sources, fills arguments, fetches the data — then EXTRACTS the answer using ONLY what the tool result contains. Returns {answer, evidence (verbati

  • search_within

    Semantic search INSIDE a fetched record. Pass the text you already pulled (e.g. a SEC 10-K body, an article, a long tool result) plus a natural-language query; get back the top-N passages with character offsets and similarity scores. Use when the record is too big to cram into th

  • deep_research

    ACCOUNT REQUIRED (free — sign in via GitHub at https://pipeworx.io/signup; depth:"thorough" needs a paid plan). If you are not signed in, use ask_pipeworx instead — it works on every tier. Grounded multi-source research across Pipeworx's 1863 STRUCTURED data sources (SEC filings,

  • discover_tools

    Find tools by describing the data or task. Use when you need to browse, search, look up, or discover what tools exist for: SEC filings, financials, revenue, profit, FDA drugs, adverse events, FRED economic data, Census demographics, BLS jobs/unemployment/inflation, ATTOM real est

  • resolve_entity

    "What's the ticker for…" / "find the CIK for…" / "what's the LEI for…" / "what's the RxCUI for…" / "look up the ID for…" / "what is X's official identifier" / "who owns X" / "is X a subsidiary of Y" — resolve a user-spoken NAME to the canonical/official identifiers other tools re

  • compare_entities

    "Compare X and Y" / "X vs Y" / "X versus Y" / "which is bigger / better / larger / more profitable" / "rank these companies" / "head to head" — side-by-side comparison of 2–5 companies or drugs in ONE parallel call. ALWAYS PREFER over sequential single-pack lookups when comparing

  • subscribe

    Create a proactive monitoring subscription to a live-data event stream. Returns the new subscription id. Requires a Pipeworx OAuth account (anonymous + BYO cannot persist subscriptions). Supported types: "sec_8k" (8-K filings matching ticker + item codes — e.g. items:["5.02"] = o

  • unsubscribe

    Cancel a subscription by id. Ownership is enforced — you can only cancel your own subscriptions. The row is deactivated (not deleted) so its historical events stay available via recent_alerts.

  • list_subscriptions

    List the caller's active subscriptions. Returns id, type, params, created_at, last_fired_at, fire_count for each. Use this to review what you're monitoring before adding more or to find an id to cancel.

  • recent_alerts

    Pull fired events from your subscription feed. Returns the most recent alerts the evaluator has written to your persisted feed — each carries source, citation_uri (pipeworx:// when available), and the raw event payload. Filter by type (e.g. "sec_8k") and/or since (ISO timestamp).

  • entity_profile

    "Tell me about X" / "research Acme" / "brief me on Tesla" / "what does Apple do" / "company profile for Microsoft" / "give me the rundown on NVDA" / "everything you know about $TICKER" — full cross-source profile of a US public company in ONE parallel call. ALWAYS PREFER over cha

  • recent_changes

    "What's new with X" / "latest on Y" / "what happened to Z this week / month / quarter" / "updates on Acme" / "news on Tesla recently" / "what's happening with Apple" — change feed for a company in the last N days/weeks/months in ONE parallel call. Fans out to SEC EDGAR (filings s

  • validate_claim

    "Is it true that…" / "fact check" / "verify the claim that…" / "did X really…" / "was Y actually…" / "confirm or refute" / "true or false" — natural-language claim verification against authoritative sources. Use whenever the agent needs to check whether something a user said is f

  • company_facts

    TYPED, DETERMINISTIC financial facts for a US public company for an EXPLICITLY NAMED reporting period — "Apple revenue for fiscal 2023", "Walmart net income FY2026 Q3", "Microsoft cash at the end of fiscal 2024". PREFER OVER entity_profile / get_company_financials whenever the pe

  • company_register_search

    Search the NATIONAL BUSINESS REGISTERS by company name and get the register's own id back — a Companies House number, a Norwegian organisasjonsnummer, a Finnish business id, a SIREN, a Japanese corporate number, an Estonian registry code, a CNPJ, or an LEI. Use this when you want

  • scan_dependency

    Composite "should I add this npm package to my project" check in ONE call — fans out across deps.dev (license + advisories + version history) and bundlephobia (gzipped/minified bundle size, dependency count, ESM/tree-shake support). Use whenever an agent asks "is X safe / popular

  • bet_research

    Research a Polymarket bet by pulling the relevant Pipeworx data for it in one call. Pass a market slug ("will-kristi-noem-win-the-2028-republican-presidential-nomination"), a polymarket.com URL, or a question text. A dated slug ("...-by-june-30-2026") still resolves after it sett

  • polymarket_arbitrage

    Find arbitrage opportunities on Polymarket via monotonicity violations + partition-sum checks. Call with NO args for a `trending_scan` of the top ~200 markets by weekly volume; pass `event` for the strongest per-event partition_check, or `topic` for a themed cross-event scan. `ev

  • polymarket_edges

    Scan top Polymarket markets and return opportunities where Pipeworx data disagrees with market price. Built for "what should I bet on today" — agents discover opportunities without paging hundreds of markets. FIVE MODEL FAMILIES grouped into three response segments under by_segme

  • polymarket_kalshi_spread

    Cross-venue spread between Kalshi and Polymarket for the same resolving question. The two venues sometimes price the same outcome 2-25pp apart because their participant pools differ — when the bet shapes are equivalent that delta is a real signal, when they aren't the tool says s

  • polymarket_fill_risk

    Realizable-vs-theoretical edge check against live CLOB order-book depth — AND Polymarket's own taker fee, which is never zero and is folded in rather than left for you to add (fleet #3446: r/PredictionsMarkets flagged a "clean" fill that quietly omitted it as optimistic in the di

  • polymarket_edge_tracker

    Edge persistence and decay telemetry built from daily polymarket_edges snapshots. Answers "how long has this edge existed and is it shrinking?" — a fresh wide edge and a 3-week-old wide edge are different trades (the latter is wide for a reason nobody is willing to take). Args: d

  • kalshi_weather_edge

    Prices Kalshi daily high-temperature markets against the NWS forecast for the market's OWN settlement station, and measures whether that forecast actually beats the market. Two modes. LIVE (default): returns the full strike ladder for one city and settlement date with market_prob

  • resolution_audit

    Extract the settlement clause of a single Polymarket (.com or .us) or Kalshi market: who publishes the settling number (source), the clock time + timezone it is taken at (falling back to the market TITLE when the clause itself says "the time range specified in the title" — e.g. P

  • resolution_diff

    Field-by-field diff of TWO markets' settlement clauses (one from each of `a` and `b`; either can be Polymarket .com, Polymarket US, or Kalshi) — runs resolution_audit on both sides and compares source, settle time, precision, comparison_basis, and evidence standard. Returns `equi

  • release_calendar_markets

    JOIN of the official release calendar (econ data, the FOMC, FDA decisions, SEC rules) against LIVE Polymarket/Kalshi markets — which scheduled releases land in the next N hours, and which live markets resolve on them. This is a POSITIONING tool, not a speed product: results are c

  • prediction_calibration

    REALIZED win rate by shown price and minutes elapsed for short-horizon crypto up/down markets, net of taker fee — read from our own settled-outcomes archive, not from live prices. Answers the one question no venue will: "a side shown at 82 with five minutes left, how often did it

  • updown_venue_compare

    The same 15-minute crypto "up or down" window priced on polymarket.com, Polymarket US and Kalshi, side by side, with whether each pair is actually the same contract. Pass asset (btc | eth | sol | xrp | bnb) and window ("current" default, "next", "previous", or the window START as

  • updown_divergence_rate

    How often two venues settled the SAME 15-minute crypto window differently, over every settled window on record. Compares polymarket.com (Chainlink TWAP) with Kalshi and with Polymarket US (both CF Benchmarks BRTI), and Kalshi with Polymarket US as the same-feed control. Per pair:

  • archive_evidence

    What did a web page say on a given date? Finds the archived capture of a URL nearest that date across the Internet Archive Wayback Machine, Common Crawl and Arquivo.pt, reads it, and returns the readable text (HTML stripped) with the capture timestamp, a link to the archived copy

  • archive_compare

    What changed on a web page between two dates? Resolves the archived capture nearest each date (Internet Archive Wayback Machine, Common Crawl, Arquivo.pt), extracts the readable text of both, and returns a text-level diff: the segments removed and added, a similarity score, and b

  • research_row

    Claygent-style per-row research: answer ONE question about ONE company and return a JSON object matching your output_schema, with every field wrapped in its own evidence — {value, evidence_url, quote, status}. status is NEVER self-reported by the model: "found" means this code in

  • classify_row

    Cheap categorization: given a company and a list of candidate labels, decide which labels apply — the most common GTM/AI usage shape (tagging a list by industry, ICP fit, etc.), one small model call. Same evidence contract as research_row: each label comes back {label, applies, e

  • pipeworx_trending

    What other AI agents are calling on Pipeworx right now. Returns the top tools, top packs, and total call volume over a recent window (24h, 7d, or 30d). Useful for: (1) discovering what data sources are hot for current events, (2) confirming a popular tool is the canonical choice

  • suggest_questions

    What can I ask Pipeworx? / what is Pipeworx good for? / what can you do? / give me ideas / show me examples / getting started / what data do you have? — the onboarding entry point for an agent that just connected and wants to know what is worth asking. Returns category-bucketed e

  • generate_llms_txt

    Generate a production-ready llms.txt file for any URL so AI crawlers (ChatGPT, Claude, Perplexity) can index the site cleanly. Fetches the page, extracts title/description/key links, and emits the standard llms.txt markdown format. Output is a single text blob ready to drop at si

  • ai_visibility_check

    Probe one or more LLMs for what they know about a business / brand / product / topic and score visibility (0-100) per model. Default model is Workers AI Llama-3.3-70b (free); pass `_apiKey` to also probe Anthropic (BYO key — you pay Anthropic directly for those calls). Returns pe

  • scan_competitor_ai_presence

    Compare AI visibility across multiple entities side-by-side. Probes each entity (your brand + N competitors) with ai_visibility_check, ranks by score, surfaces which is most/least recognized. Useful for competitive AI-marketing audits: "does Claude know about us as well as our co

  • pipeworx_feedback

    Tell the Pipeworx team something is broken, missing, or needs to exist. Use when a tool returns wrong/stale data (bug), when a tool you wish existed isn't in the catalog (feature/data_gap), or when something worked surprisingly well (praise). ONLY for tools served by this Pipewor

  • remember

    Save data the agent will need to reuse later — across this conversation or across sessions. Use when you discover something worth carrying forward (a resolved ticker, a target address, a user preference, a research subject) so you don't have to look it up again. Stored as a key-v

  • recall

    Retrieve a value previously saved via remember, or list all saved keys (omit the key argument). Use to look up context the agent stored earlier — the user's target ticker, an address, prior research notes — without re-deriving it from scratch. Scoped to your identifier (anonymous

  • forget

    Delete a previously stored memory by key. Use when context is stale, the task is done, or you want to clear sensitive data the agent saved earlier. Pair with remember and recall.

  • fda_device_510k_search

    Search FDA 510(k) premarket notifications by device, applicant, product code, K number, review panel, clearance type, decision, applicant location, third-party review status, or device-category text (via `indication`). Covers IN VITRO DIAGNOSTIC (IVD) tests and diagnostic devices

  • fda_device_510k_summary

    Get the FDA 510(k) summary/statement document and FDA review (decision memo) for one clearance, by K number — the actual filing, not just the "a document exists" flag from fda_device_510k_search. Shows the predicate device claimed and the testing behind the equivalence finding. O

  • fda_device_pma_search

    Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, PMA number, or CLINICAL INDICATION/condition text (via `indication`). Which diagnostic tests are FDA-approved: covers high-risk IN VITRO DIAGNOSTIC (IVD) tests approved v

  • fda_device_recalls

    Search FDA medical-device recall records by firm, product, product code, K number, status, or date. A recall record describes a correction/removal action and does not by itself establish patient harm.

  • fda_device_adverse_events

    Search FDA MAUDE medical-device reports by manufacturer, brand/device, product code, event type, or PMA/510(k) number. MAUDE reports are unverified signals: they cannot establish causation, incidence, prevalence, or comparative safety.

  • fda_device_event_counts

    Aggregate MAUDE reports for a device query by event type, manufacturer, product code, or receive date. Counts reflect reporting and database artifacts—not event rates or causal risk—and must not be compared without exposure denominators.

  • fda_device_company_profile

    Build a bounded FDA regulatory snapshot for one device company across 510(k), PMA, recalls, and MAUDE. Dataset name matching is imperfect and MAUDE counts are signals, not safety rates.

  • fda_device_classification

    Look up FDA device classification and regulatory context by product code, device name, or regulation number. Classification describes the product-code category, not a specific product’s clearance or approval.

  • fda_device_udi_search

    Search FDA GUDID/UDI records by brand, company, device identifier, or product code. A UDI record describes an identified device in GUDID; it does not establish current sales, availability, clearance, approval, or safety.

  • fda_device_establishment_search

    Search FDA device registration/listing data by firm, registration number, product code, or listing number. Registration/listing does not mean FDA approval, clearance, certification, or endorsement.

  • fda_device_product_code_profile

    Build a bounded cross-dataset snapshot for one FDA product code: classification, recent 510(k)s, PMAs, recalls, and MAUDE reports. Dataset counts have different meanings; MAUDE counts are not event rates.

ผลตรวจเบื้องต้นi

เราตรวจจากข้อมูลที่ใครก็เปิดดูได้ ยังไม่ได้อ่านโค้ด ข้อที่ไม่เกี่ยวกับตัวนี้ไม่นับในตัวหาร · ตรวจเมื่อ 9 พ.ย. 2569

  • ✓ ผ่าน

    ตัวตนผู้ทำตรงกับ repo

    ชื่อใน registry ยืนยันด้วยบัญชี GitHub pipeworx-io ซึ่งเป็นเจ้าของ repo

  • … ยังไม่ตรวจ

    ยังมีคนดูแล

    ยังไม่ได้อ่านข้อมูล repo จาก GitHub

  • … ยังไม่ตรวจ

    มีสัญญาอนุญาต (license)

    ยังไม่ได้อ่านข้อมูล repo จาก GitHub

  • ✓ ผ่าน

    endpoint ตอบ

    ตอบกลับใน 296 ms (HTTP 200)

  • – ไม่เกี่ยว

    ล็อกอินแบบ OAuth

    ไม่ต้องล็อกอิน

  • ✓ ผ่าน

    คำอธิบายเครื่องมือไม่มีคำสั่งแอบแฝง

    อ่านคำอธิบายเครื่องมือ 55 ตัวแล้ว ไม่พบคำสั่งแอบแฝงถึง AI

เทียบกับตัวอื่นในหมวด คลินิกและสุขภาพi

  • ดาวมากกว่า 0% ของอีก 1034 ตัวในหมวดนี้
  • ส่งรุ่นใหม่เข้า registry ล่าสุดกว่า 76% ของอีก 1034 ตัวในหมวดนี้
  • ผลตรวจเบื้องต้นดีกว่าหรือเท่ากับ 100% ของอีก 1034 ตัวในหมวดนี้

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Fda Devices ปลอดภัยไหม?

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Mirobody

Lab results to LOINC codes and UCUM units, symptoms and diagnoses to ICPC-3. Offline, no API key.

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MCP server providing seamless access to FHIR APIs for AI tools and healthcare applications

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Privacy-first unofficial Google Health API v4 MCP server for health, sleep, activity, HR agents

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@pipeworx/fda-devices

FDA medical-device regulatory intelligence: 510(k) premarket clearances (including De Novo classification requests), PMA approvals, recalls, MAUDE adverse-event reports, device classification, GUDID/UDI identifiers, and establishment registration/listing. Keyless.

Part of Pipeworx — an MCP gateway connecting AI agents to 1864+ live data sources. This is an independent, unofficial integration — not affiliated with, endorsed by, or published by the upstream provider.

Tools

  • fda_device_510k_search(device?, indication?, applicant?, product_code?, k_number?, from_date?, to_date?, advisory_committee?, clearance_type?, decision?, applicant_country?, applicant_state?, third_party_review?, limit?, skip?) — search 510(k) premarket notifications. Also covers De Novo classification requests (K numbers beginning DEN, e.g. DEN250057) — pass clearance_type: "De Novo" to find only these, or an exact k_number. A granted De Novo shows decision: "Granted", clearance_type: "De Novo", the FDA process variant in de_novo_pathway ("Direct" or "Post-NSE"), and the new device-classification regulation_number it created.
  • fda_device_510k_summary(k_number) — the actual 510(k) summary/statement and FDA review (decision memo) document for one clearance, scraped off FDA's own detail page since openFDA does not expose the file itself. Older/paper-only filings return summary_available: false with a reason, not an error.
  • fda_device_pma_search(device?, indication?, applicant?, product_code?, pma_number?, from_date?, to_date?, limit?) — search Premarket Approval (PMA) decisions and supplements, including by the FDA approval-order narrative text (indication) for high-risk IVD/companion-diagnostic claims.
  • fda_device_recalls(query?, firm?, product_code?, k_number?, status?, from_date?, limit?) — medical-device recall (correction/removal) records.
  • fda_device_adverse_events(device?, manufacturer?, product_code?, event_type?, application_number?, from_date?, limit?) — MAUDE adverse-event reports. Signals, not causal safety rates.
  • fda_device_event_counts(query?, count_field, limit?) — aggregate MAUDE reports by device, manufacturer, event type, product code, or date.
  • fda_device_company_profile(company, limit_per_dataset?) — bounded cross-dataset snapshot (510(k)/De Novo, PMA, recalls, MAUDE) for one company.
  • fda_device_classification(product_code?, device?, regulation_number?, limit?) — FDA device classification/regulatory category lookup.
  • fda_device_udi_search(query?, company?, primary_di?, product_code?, limit?) — GUDID/UDI device identifier records.
  • fda_device_establishment_search(firm?, registration_number?, product_code?, listing_number?, limit?) — device registration/listing records.
  • fda_device_product_code_profile(product_code, limit_per_dataset?) — bounded cross-dataset snapshot (classification, 510(k)/De Novo, PMA, recalls, MAUDE) for one product code.

Every call rejects unknown argument names rather than silently ignoring them.

Auth

Keyless.

Data sources

  • U.S. Food and Drug Administration (FDA), openFDA device datasets — 510(k) premarket notification (which also carries De Novo classification requests), Premarket Approval (PMA), medical device recall enforcement reports, MAUDE adverse event reports, device classification, GUDID/UDI, and device registration & listing.
  • U.S. FDA CDRH, 510(k) Premarket Notification database — the authoritative detail page for one clearance's summary/review document link, used only by fda_device_510k_summary because openFDA itself does not expose the document.
Gotchas
  • De Novo records share the 510(k) endpoint, and openFDA's own decision/clearance-type text for them is wrong on its face. A De Novo grant's K number begins DEN (e.g. DEN250057), and openFDA's decision_code for every one of them is DENG — but openFDA's own decision_description lookup for that code (and five older legacy 510(k) codes: Kit, Kit-With-Drugs, With-Drug, With-Limitations, Postmarket-Surveillance-Required) is the literal string "Unknown", and its clearance_type for a De Novo record is "Direct" or "Post-NSE" — FDA's own PROCESS VARIANT for how the De Novo was handled, not a 510(k) clearance type. Confirmed live 2026-10-21 against FDA's own De Novo detail page, which labels the decision literally "granted (DENG)". This pack maps decision_code through its own label table (decision: "Granted") and remaps clearance_type to "De Novo" with the process variant preserved in de_novo_pathway, rather than passing openFDA's confusing raw text through. clearance_type: "De Novo" and decision: "Granted" as filter arguments are translated to the matching decision_code/clearance_type values server-side, since openFDA itself stores neither string literally.
  • `indication` on 510(k) is a best-effort device-category bridge, not a clinical-claim search — 510(k) records carry no indication/intended-use text at all. It matches FDA's device classification category name/definition instead. For a real clinical-indication text search (useful for molecular/companion-diagnostic claims), use fda_device_pma_search's indication, which searches FDA's actual approval-order narrative.
  • MAUDE's `manufacturer_name` field is populated on essentially no records (25.7M rows, almost all empty string) while device.manufacturer_d_name is the real one — fda_device_adverse_events's manufacturer argument searches the latter. A dead field 404s identically to "no matches", so every response names which fields were actually searched.
  • The most recent decision available lags roughly two weeks behind FDA's own site — openFDA's publishing cadence, not ours.
  • fda_device_510k_summary's K-number PDF directory path is not derivable from the K number (year-segment naming is inconsistent, pre-2000 filings have no year segment at all) — the tool scrapes the actual link off FDA's detail page rather than guessing a path that could 404 for either "wrong guess" or "never digitized".

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

{

"mcpServers": { "fda-devices": { "url": "https://gateway.pipeworx.io/fda-devices/mcp" } } }

What this endpoint actually serves

tools/list at https://gateway.pipeworx.io/fda-devices/mcp returns the tools in the table above plus the shared Pipeworx meta-tools — ask_pipeworx, discover_tools, search_within, remember/recall and the rest of the gateway-wide set. So the tool count you see is larger than this table: a single-pack endpoint currently lists roughly 30 shared tools alongside the pack's own. The connection's initialize response states its exact scope, and is the authoritative answer for a given day.

This is deliberate, not multiplexing by accident. The meta-tools are what let a scoped connection answer a question this pack does not cover — via ask_pipeworx, which routes across the whole catalog — without you adding a second MCP server. There is currently no way to mount a pack endpoint without them; if the extra schemas cost you more context than the routing is worth, connect to the full gateway once rather than to several pack endpoints.

Or connect to the full Pipeworx gateway to get every pack's tools listed directly, instead of just this one's:

{

"mcpServers": { "pipeworx": { "url": "https://gateway.pipeworx.io/mcp" } } }

Both URLs reach the same gateway and the same 1864+ data sources. The only difference is which pack's tools are listed directly; ask_pipeworx reaches all of them from either one.

No MCP client? Call it over HTTP

curl -X POST https://gateway.pipeworx.io/v1/tools/fda_device_510k_search \

-H 'Content-Type: application/json' \ -d '{"device":"glucose monitor","from_date":"2025-01-01","limit":10}'

No account needed for the first calls. Inspect any tool: GET https://gateway.pipeworx.io/v1/tools/fda_device_510k_search. Find one: POST https://gateway.pipeworx.io/v1/tools/search_packs with {"query":"..."}.

Run it from npm

@pipeworx/mcp-fda-devices is a local stdio bridge to the Pipeworx gateway: your MCP client starts it with npx, and it forwards every call to the same https://gateway.pipeworx.io/fda-devices/mcp endpoint shown above. It needs network access; there is no offline mode.

{

"mcpServers": { "fda-devices": { "command": "npx", "args": ["-y", "@pipeworx/mcp-fda-devices"] } } }

Without a key it calls anonymously, capped at 50 calls a day. A free account raises that to 200 a day: get a key at https://pipeworx.io/signup and add "env": { "PIPEWORX_API_KEY": " " } to the server entry. The key is sent as a Bearer token, the same way a hosted connection sends it, so calls are metered and billed exactly as they are there.

It lists only this pack's tools by default. Set PIPEWORX_META_TOOLS=1 to also list ask_pipeworx and the other gateway-wide tools.

Behind an HTTPS proxy: Node's built-in fetch does not read HTTPS_PROXY by default. Newer Node releases honour it when NODE_USE_ENV_PROXY=1 is set; check your Node version's documentation.

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English — this works on the pack endpoint above as well as on the full gateway:

ask_pipeworx({ question: "your question about Fda Devices data" })

The gateway picks the right tool and fills the arguments automatically.

More

License

MIT

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