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.

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Establishment Name
Owner/Operator Name
Proprietary Name
Product Code
Establishment State (U.S.)

Registration Number
Owner/Operator Number
Classification Device Name
Establishment Type
Establishment Country

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Other Databases

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Registration & Listing
Adverse Events (MAUDE)
Recalls
Premarket Approvals (PMAs)
Inspections
Device Classification
Standards
Total Product Life Cycle
CFR Title 21
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Medsun Reports
CLIA

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