Establishment Registration & Device Listing - Food and Drug …
4 days ago · 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 by FDA.
MDR Database Search - Food and Drug Administration
MDR Database SearchFDA Home Medical Device Databases
www.accessdata.fda.gov
Access the FDA's Center for Drug Evaluation and Research resources, including drug approvals, databases, and regulatory information.
Product Classification - Food and Drug Administration
Dec 1, 2025 · 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...
CFR - Code of Federal Regulations Title 21 - Food and Drug …
Dec 24, 2024 · Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products
Manufacturer and User Facility Device Experience (MAUDE) Database
Nov 30, 2025 · The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters …
198 Several FDA-approved commercial assays are available to aid in the selection of breast cancer and 199 metastatic gastric cancer patients for Herceptin therapy.
label - Food and Drug Administration
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------USE IN …
Mammography Facilities - Food and Drug Administration
4 days ago · The Mammography Facility Database is updated periodically based on information received from the three FDA-approved accreditation bodies: the American College of Radiology (ACR), and …
Leqembi (lecanemab-irmb) injection - Food and Drug Administration
To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and …