About Fda Devices
Fda Devices is an MCP server in the Healthcare category: fDA medical-device regulatory intelligence from keyless openFDA datasets.
Install
From source
git clone https://github.com/pipeworx-io/mcp-fda-devicesThis server has no ConduID identity, so agent calls to it are not receipted. Pin the version you install and review the source before granting it credentials.
Tools (10)
fda_device_510k_searchSearch FDA 510(k) premarket notifications by device, applicant, product code, or K number. Clearance means FDA found substantial equivalence; it is not an FDA approval or endorsement.
Parameters not published.
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, prevalence, or comparative safety.
Parameters not published.
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 approval.
Parameters not published.
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.
Parameters not published.
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.
Parameters not published.
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 compared without exposure denominators.
Parameters not published.
fda_device_pma_searchSearch FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, or PMA number. Supplements may represent manufacturing or labeling changes rather than new devices.
Parameters not published.
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 rates.
Parameters not published.
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.
Parameters not published.
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, approval, or safety.
Parameters not published.
Ask AI
✦
Ask AI about Fda Devices
Powered by Claude · Grounded in docs
I know everything about Fda Devices. Ask me about installation, configuration, usage, or troubleshooting.
Security checks
6 checks have not been run yet.