Establishment Registration & Device Listing

This database includes: medical device manufacturers registered with FDA and medical devices listed with FDA 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. You can enter a premarket submission number, a company name, registration or owner/operator number to search for registration and listing information. Learn More...

Other Databases 510(k)s De Novo Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room CFR Title 21 CLIA Device Classification FDA Guidance Documents Humanitarian Device Exemption Medsun Reports Premarket Approvals (PMAs) Post-Approval Studies Postmarket Surveillance Studies Radiation-Emitting Products Radiation-Emitting Electronic Products Corrective Actions Recalls Registration & Listing Standards Total Product Life Cycle X-Ray Assembler

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