Is there an easy way to access medical device approvals? (Including being able to sort the approvals by manufacturer?) Currently you are able to view "recently-approved devices." Hoping to be able to access approvals beyond just recent ones.

2 Answers 2


I see you added the openfda tag to this question but this doesnt seem to be data that is available from openFDA. The data regarding devices that openFDA has is enforcement reports (https://open.fda.gov/device/enforcement/) and adverse events.

If you are determined to get this data from openFDA, you could.. sorta kinda. You can gather data about devices that have had at least one adverse event by getting a list of manufacturers by going to https://api.fda.gov/device/event.json?&count=device.manufacturer_d_name.exact&limit=1000 and the doing queries for all events related to a manufacturer (https://api.fda.gov/device/event.json?&search=device.manufacturer_d_name.exact:KENDALL). This is probably not a good idea because you will have to de-duplicate events from devices but it is an option for using currently open openFDA data for this case.

Moving on from openFDA to the general info on FDA.gov including the link you posted, you are looking for data older than 2008 or are you in need of a way to search those data (in which case a scraper will likely need to be created)?

EDIT: You might be interested in this news story from Modern Healthcare: FDA urged to encourage development of medical-device registries

EDIT 2: My colleague found this, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm089428.htm, on FDA.gov. It is 510(k) data going back to 1976.


TO add to Marks post I uploaded the 510K files to Socrata open data which creates a way for you to visualize the data in the .zip files he posted the link to and also leverage an API endpoint http://opendata.socrata.com/resource/nz8c-mqph.json?$limit=10

You can see it on Socrata at https://opendata.socrata.com/Government/510-k-Clearances/nz8c-mqph

I also whipped up a map as well at https://opendata.socrata.com/Government/510k-Clearance-Location-Heatmap/bc9v-7hg7

Your Answer

By clicking “Post Your Answer”, you agree to our terms of service, privacy policy and cookie policy

Not the answer you're looking for? Browse other questions tagged or ask your own question.