FDA no longer lists Medical Device Proprietary Names

Hi,

I am looking at the FDA's Establishment Registration and Device Listing database. It used to be, when I entered the name of a company and the proprietary name of one of their devices, I could see the proprietary device name and the FDA Classification (for example 862.2100-Calculator/Data Processing Module for Clinical Use) under which the device was listed.

Now, all I see is the company name and associated FDA Classification.


Does anyone know why the FDA no longer provides the proprietary name? Is there another place to search?

A quick "Bump". My Thanks in advance to anyone who can help with this one.

Wish I could be more help, but it is stange that one of their search fields (proprietary name) is not included in the returned data. It looks like someone did not do proper validation on their system.

If you want to take the time the information is still available in the 510K database, with the limit that the company you are interested in has the 510K for the product and is not just rebranding.

I've recently received very quick and informative responses to a couple of device listing questions I had directly from the FDA at: [email protected].

I doubt if this was an intended change in the public database. Proprietary names are still required in Listing entries into the internal database.

They still do, here's an example. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?lid=178370&lpcd=LFL