mcp-fda-devices

Tool

Description

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 devices.

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.