Establishment Registration & Device Listing - Food and Drug …
Jan 26, 2026 · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products …
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Access the FDA's Center for Drug Evaluation and Research resources, including drug approvals, databases, and regulatory information.
Product Classification - Food and Drug Administration
Jan 26, 2026 · This database includes: a list of all medical devices with their associated classifications, product codes, FDA Premarket Review organizations, and other regulatory information. learn more...
MDR Database Search - Food and Drug Administration
MDR Database Search FDA Home Medical Device Databases
Manufacturer and User Facility Device Experience (MAUDE) Database
Dec 31, 2025 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters …
label - accessdata.fda.gov
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-934-6891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CFR - Code of Federal Regulations Title 21 - Food and Drug …
Dec 24, 2024 · FDA Guidance Documents Humanitarian Device Exemption Medsun Reports Premarket Approvals (PMAs) Post-Approval Studies Postmarket Surveillance Studies Radiation-Emitting …
Mammography Facilities - Food and Drug Administration
Jan 26, 2026 · The Mammography Facility Database is updated periodically based on information received from the three FDA-approved accreditation bodies: the American College of Radiology …
Devices@FDA - Food and Drug Administration
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Scientific Publications by FDA Staff
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