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Check whether a medical device establishment's FDA registration is current. Search by company name, registration number, or FEI number. Results come from the openFDA public database — informational, not an official FDA record.
Why It Matters
FDA establishment registration is not optional — distributing devices without a current registration is a prohibited act under Section 502(o) of the FD&C Act, which misbrands any device whose required notices haven't been filed. Foreign establishments that fall out of good standing face import detention the moment an unregistered shipment hits a US port of entry. The renewal window runs October 1 – December 31 every year; missing it means your registration lapses on January 1. ADB's Registration + Listing service includes annual renewal management to eliminate that risk entirely.
Common Questions
Use the free lookup tool above to search by company name, registration number, or FEI. Enter your search term, select the field type, and the tool queries the openFDA public database in real time. For the authoritative FDA record, verify at FDA's FURLS database at fda.gov.
This tool queries the openFDA public database, which refreshes periodically and may lag FDA's live FURLS system by several days or weeks. A registration completed recently — or a renewal submitted close to the October 1 deadline — may not appear immediately. These results are informational only; for official status, check FDA's FURLS database directly.
An expired or lapsed FDA establishment registration puts your operation out of compliance. Distributing devices without a current registration is a prohibited act under Section 301 of the FD&C Act. Foreign establishments risk import detention; domestic establishments risk warning letters and injunctions. The annual renewal window runs October 1 – December 31. ADB's registration services include renewal management to prevent lapses.
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Flat-fee establishment registration, device listing, US Agent services, and annual renewal management — handled by senior FDA regulatory consultants.