Fda Devices
liveLegalHealthDeveloperFDA medical-device regulatory intelligence from keyless openFDA datasets.
Tools
fda_device_510k_searchSearch 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 (
No parameters required.
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fda_device_510k_summaryGet 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. Show
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fda_device_pma_searchSearch 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 tes
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fda_device_recallsSearch 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.
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fda_device_adverse_eventsSearch 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,
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fda_device_event_countsAggregate 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 co
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fda_device_company_profileBuild 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.
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fda_device_classificationLook 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 a
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fda_device_udi_searchSearch 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,
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fda_device_establishment_searchSearch 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.
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fda_device_product_code_profileBuild 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 ra
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Test with curl
The gateway speaks JSON-RPC 2.0 over HTTP POST. You can test any pack directly from the terminal.
curl -X POST https://gateway.pipeworx.io/fda-devices/mcp \
-H "Content-Type: application/json" \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}'curl -X POST https://gateway.pipeworx.io/fda-devices/mcp \
-H "Content-Type: application/json" \
-d '{"jsonrpc":"2.0","id":2,"method":"tools/call","params":{"name":"fda_device_510k_search","arguments":{}}}'Use with the SDK
Install @pipeworx/sdk to call tools from any TypeScript/Node project.
import { Pipeworx } from '@pipeworx/sdk';
const px = new Pipeworx();
const result = await px.call("fda_device_510k_search", {});// Or ask in plain English:
const answer = await px.ask("fda medical-device regulatory intelligence from keyless openfda datasets");