S&P Global Market Intelligence: FDA Pre-Market Notifications 510(k) Filings

510(k) Filings are notifications by a company that they intend to market a medical device.

Description:

Pre-Market Notifications 510(k) Filings is one of three datasets offered by S&P Global Market Intelligence from the U.S. Food and Drug Administration (FDA). 510(k) filings are notifications by a company that they intend to market a medical device, which must be filed 90 days prior to device being marketed.

Dataset Overview:
Primary Entity Type: Company
Coverage Count: 150,000
Geographic Coverage: United States and Canada
Industry Coverage: Healthcare
History Initiated: 1976
Data Source: FDA.gov

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