Terms
What You May Rely on, and What You May Do With the Pages.
What a Page States
Read From the Filing on Its Build Date
Every page states what a public filing says: that a company holds a registration, that a device is listed under a product code, that a clearance was granted or a recall issued, as of the build date each record prints. A filing can change after that date, and a page changes only with the next release.
A registration is a filing the regulator holds and publishes. It says what a plant is set up to make. It is not an approval of the company or of anything it makes, and it says nothing about quality. A clearance is a decision about one device under one filing and not a certificate for the company. The site does not verify that a company is trading, that a device is available, that it is fit for any purpose, or that it may lawfully be placed on any market.
The filed record carries no prices and no stock. A manufacturer missing from the index has not registered for the United States market, and nothing more follows from that.
What It Is Not
The Site Sells Nothing and Advises No One
Nothing on the site is an offer of sale, a recommendation of any company or device, or regulatory or medical advice. A buyer who acts on a record confirms it with the manufacturer and with the authority that issued it, and remains responsible for what the destination market requires of the device and of its importer.
Statements Added by Manufacturers
The Publisher Does Not Adopt Them
Where a page carries a statement the manufacturer itself added, the publisher does not verify it and does not adopt it. The manufacturer answers for it.
Use of the Site
What You May Do With the Pages
You may read the pages, link to any of them and quote from them, naming the page as the source. You may not copy the index in bulk, republish its pages or any substantial part of them, or send automated requests at a rate that degrades the service for other readers. The structured data on record pages exists so that search engines and assistants can cite the page. It is not a bulk feed.
Errors, Liability and Law
Where the Publisher Stops
An error in a record, or a statement that should not stand, is reported through the contact page. The site is provided as it is. To the extent the law allows, the publisher accepts no liability for decisions taken on the strength of a record, for the accuracy of a filing as its filer made it, for a statement a manufacturer added, or for interruptions of service. These terms are governed by the law of the country in which the publisher is established. The publisher may change them, and the version published at the time of reading applies.