FDA-cleared AI medical devices: source list
FDA-cleared AI medical devices: source list
The available evidence does not identify a dedicated FDA database or comprehensive list specifically for AI-enabled medical devices authorized for clinical use. The most relevant official starting point is FDA’s 510(k) Premarket Notification Database, but users must verify AI functionality and clinical relevance in each device record rather than assume every listed device is AI-enabled or clinically appropriate.[1]
Official FDA clearance database
Use this FDA database to search devices cleared through the 510(k) pathway. It is an official clearance resource, not an AI-specific list, so individual records require device-level review.[[cite:2]][[cite:3]][[cite:4]]
510(k) Premarket Notification
FDA software and digital-health context
These FDA pages help interpret device software and digital-health terminology when reviewing potential AI-enabled products, but they do not constitute a comprehensive AI-device clearance list.
FDA companion-diagnostic list
This is an official FDA list for authorized companion diagnostic devices, including in vitro and imaging tools. It is narrower than a general AI-medical-device list and should not be used as a substitute for one.
Do not use as clearance lists
MAUDE is an adverse-event reporting database, not an authorization or clearance database. The FDA generative-AI announcement provides regulatory context, not a comprehensive list of clinically authorized AI devices.[[cite:10]]
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