@pipeworx/fda-devices

Connect: https://gateway.pipeworx.io/fda-devices/mcp · Install: one-click buttons

Tools: 10

Tools

• fda_device_510k_search — Search 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.
• fda_device_pma_search — Search 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
• 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,
• 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 co
• 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 a
• 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,
• 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 ra