Medical Device Safety Dashboard

Real-time FDA medical device clearances and safety recalls. Monitor 510(k) approvals, device classifications, and enforcement actions.

Search FDA's 510(k) database (172K+ device clearances) and enforcement reports (current recalls)

🏥 Recent Device Clearances

FDA 510(k) approvals (updated 8/18/2025)
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⚠️ Device Recalls & Safety Alerts

FDA enforcement reports (updated daily)
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Understanding Recall Classifications

Class I
Most Serious
Dangerous/defective products that could cause serious health problems or death
Class II
Moderate Risk
Products that might cause temporary health problems or slight threat of serious injury
Class III
Low Risk
Products unlikely to cause adverse health reactions but violate FDA regulations

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Live FDA Data Sources

Device Clearances: FDA 510(k) Database - Pre-market notifications and approvals for medical devices

Device Recalls: FDA Device Enforcement Reports - Safety alerts, recalls, and enforcement actions

Coverage: Surgical instruments, diagnostic equipment, implants, and medical software

Data refreshed from openFDA API. No API key required for public health data.

Medical Device Safety Information

Professional Use: This medical device dashboard is designed for healthcare professionals, device manufacturers, and regulatory affairs specialists for informational and compliance purposes.

Not Medical Advice: Device information should not be used for clinical decisions. Always consult FDA official databases and device labeling for authoritative information.

Data Limitations: Device clearance does not guarantee safety or effectiveness. Recalls and adverse events may be under investigation and subject to change.

Emergency Situations: For medical device emergencies, contact the device manufacturer directly and report adverse events to FDA MedWatch at www.fda.gov/medwatch.