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.