openFDA

FDA 510(k) premarket notification clearances: K number, applicant, device name, product code, decision and decision date.

FDA device classification records: product code, device class (I/II/III), regulation number, medical specialty and submission type required.

MAUDE reports of medical device malfunctions, injuries and deaths: the device, the manufacturer, the event narrative and patient outcome.

FDA enforcement reports for recalled medical devices: device description, recalling firm, reason, classification and status.

Global UDI Database entries: device identifier, brand and company name, version/model, sterilisation, MRI safety and GMDN terms.

FAERS adverse-event reports submitted to FDA for human drugs: the patient, the drugs taken and the reactions reported.

Structured Product Label content for marketed drugs: indications, dosage, warnings, adverse reactions and the openfda identifier block.

FDA enforcement reports for recalled human drugs: recalling firm, reason, classification, distribution area and status.

FDA drug application records: application number, sponsor, approved products and the full submission/approval history with submission dates and types.

CAERS reports of adverse events tied to foods, dietary supplements and cosmetics: products involved, consumer age/sex, reactions and outcomes.

FDA enforcement reports for recalled food products: product description, recalling firm, reason for recall, classification and status.

The National Drug Code directory entry for a marketed drug product: labeler, generic and brand name, dosage form, route, active ingredients, packaging and marketing dates.

FDA drug shortage records: generic name, company, dosage form, presentation, availability, shortage reason, status and posting dates.