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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Registration and Listing Statistics (MDUFMA FDA Performance Report July 29, 2010)

The hierachy for all tables is based on the ranking in the left-most column. For example, if an establishment is both a manufacturer and a contract manufacturer, it will be counted only as a manufacturer.

RANKESTABLISHMENT_TYPEDOMESTICFOREIGNTOTAL
1Manufacturer4934670911,643
2Contract Manufacturer311639950
3Contract Sterilizer164258
4Specification Developer13642901,654
5Reprocessor of Single Use Devices16319
6U.S. Manufacturer of Export Only Devices92092
7Repackager/Relabeler13393371,676
8Remanufacturer5257109
9Foreign Exporter0913913
10Initial Distributor/Importer4,23304,233
 Unknown14065205
 Total:12,4979,05521,552