analytics FDA Regulatory Analytics Dashboard

Real-time insights into FDA 510(k) clearances, product code trends, and regulatory activity. Updated daily from our comprehensive RegulationCard database.

Loading...
gavel

warning Legal Disclaimers & Data Usage Terms

domain FDA Data Disclaimer

Original Data Source: The data presented in this dashboard originates from publicly available FDA databases, including but not limited to:

  • FDA 510(k) Premarket Notification Database
  • FDA Product Classification Database
  • FDA Recalls Database
  • MAUDE (Manufacturer and User Facility Device Experience) Database

No FDA Endorsement: This dashboard and Cruxi are not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration (FDA) or any other government agency. The FDA has not reviewed or approved this dashboard or its data presentation.

Data Accuracy Disclaimer: While we strive to present accurate data, we make no warranties or representations regarding the accuracy, completeness, timeliness, or reliability of the data. Data may contain errors, omissions, or inaccuracies from the original FDA sources. Users should verify all data directly with FDA sources before making any regulatory decisions.

Not Official FDA Data: This dashboard presents processed and aggregated data. For official FDA information, please consult FDA.gov directly.

copyright Citation Requirements

Citation Required: Any use of this data, whether for research, publication, commercial purposes, or internal analysis, must cite both Cruxi and the original FDA sources.

Recommended Citation Format:

Cruxi. (2025). FDA Regulatory Analytics Dashboard. Retrieved [Date] from https://cruxi.ai/pages/subpages/regulatory/510k/resources/regulatory-analytics.html

Original data sources: U.S. Food and Drug Administration. (n.d.). 510(k) Premarket Notification Database. Retrieved from https://www.fda.gov/medical-devices/510k-clearances

For academic publications, always include both the Cruxi dashboard citation and the original FDA source citation.

shield Limitation of Liability

No Regulatory Advice: This dashboard is provided for informational purposes only. It does not constitute regulatory, legal, or professional advice. All regulatory decisions should be made in consultation with qualified regulatory professionals and, where applicable, the FDA.

Use at Your Own Risk: Cruxi disclaims all liability for any decisions made or actions taken based on the data presented in this dashboard. Users assume full responsibility for verifying data accuracy and ensuring compliance with all applicable regulations.

No Warranties: This dashboard is provided "as is" without warranties of any kind, express or implied. Cruxi makes no representations or warranties regarding the accuracy, completeness, or suitability of the data for any particular purpose.

description Terms of Use

By using this dashboard, you agree to:

  • Cite Cruxi and FDA as data sources in any publication or use
  • Not represent this data as official FDA data
  • Verify all data with original FDA sources before making regulatory decisions
  • Use the data in compliance with all applicable laws and regulations
  • Not hold Cruxi liable for any decisions made based on this data

For complete terms, please review our Terms of Service.

bar_chart Key Statistics

Loading statistics

trending_up Monthly Clearance Trends

show_chart 510(k) Clearances by Month (Last 12 Months)

emoji_events Top Product Codes by Clearance Count

leaderboard Most Active Product Codes

Loading product codes

new_releases Recent 510(k) Clearances

schedule Latest Clearances (Last 30 Days)

Loading recent clearances

warning Recent Safety Events

health_and_safety Recalls and Safety Communications (Last 90 Days)

Loading safety events

info About This Dashboard

This dashboard provides real-time analytics from our comprehensive RegulationCard database, which contains structured data from FDA sources including 510(k) clearances, product codes, safety events, and regulatory information. Data is updated daily and provides insights valuable for regulatory professionals, researchers, and medical device companies.

For research access to the full database, please visit our FDA Database for Research page.

science Data Source & Methodology

This dashboard queries data directly from the Cruxi RegulationCard database, which aggregates and structures information from publicly available FDA sources. All data originates from official FDA public databases.

Official FDA Sources: For the most current and official information, please consult FDA.gov directly.

Data sources include:

Update Frequency: Data is refreshed in real-time when you load or refresh this page. The underlying database is updated daily with new clearances, safety events, and regulatory changes. However, users should always verify critical information with official FDA sources.