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Premarket Notifications (510(k)s)

Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records.

Source: OpenFDATest

Data and Resources

FieldValue
Publisher
Modified
2013-11-01
Release Date
2013-11-01
Frequency
Monthly
Homepage URL
Identifier
142e5da1-24f6-4215-83e5-18a7cd813889
Temporal Coverage
Thursday, January 1, 1976 - 00:00 to Tuesday, December 31, 2013 - 00:00
License
License Not Specified
Contact Name
openFDA
Contact Email
Public Access Level
Public
Harvested from OpenFDATest
Harvest Source TitleOpenFDATest
Harvest Source URIhttps://open.fda.gov/data.json
Last Harvest PerformedThu, 01/10/2019 - 00:04