Develop and launch products the right way by leveraging our expertise in medical device development and gaining direct access to our proprietary FDA database. Stay up to date on new approvals and clearances, properly identify and classify your devices, and maintain awareness about adverse events and recalls that could impact you.

Medical Device Datasets

Our FDA research tool provides access to our proprietary FDA database. Stay ahead of industry trends and improve product development with access to device clearances and premarket approvals, classification and registration listing, and adverse events and recalls.

510(k) Clearances
GUDID
Premarket Approval
Adverse Events
Classification
Recalls
Registrations & Listings
Recall Enforcement Reports

Premarket Approval & 510(k) Clearances

New 510(k) device clearances and premarket approvals for class III devices starting scientific and regulatory review are updated monthly so you can stay apprised of the latest industry trends and make the right decisions early on in your process.

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Classification & Identification

Properly identify your device and the medical specialty (panel). Locate registered medical device establishments and the manufacturing location of existing devices. Stay up to date on the latest GUDID updates.

Medical Device Specialties Medical Device Specialties
Establishments & Devices Establishments & Devices
Device Identification Database (GUIDID) Device Identification Database (GUIDID)

Adverse Events & Recalls

Stay on top of adverse events, recalls, and recall enforcement reports. Understand the device landscape when you are developing a new device, working towards a new generation device, or monitoring the marketplace to recognize impactful events.

Adverse Events & Recalls