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The record · by company · 278 companies

Companies with more than one device in the record

278 companies hold 2 or more of the 1614 AI-enabled devices on FDA's list; 369 more hold one each and are reached through their device pages. Each company links every device FDA has authorized for it.

Retrieved from FDA's list, openFDA and MAUDE.

Every company, with its device count

The company is the applicant named on the submission, as FDA records it. A company that filed under more than one name appears under each.

The whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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