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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 April 20, 2010)

The hierarchy 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.

RANK ESTABLISHMENT_TYPE DOMESTIC FOREIGN TOTAL
1 Manufacturer 4,776 6326 11,102
2 Contract Manufacturer 302 609 911
3 Contract Sterilizer 15 41 56
4 Specification Developer 1,291 272 1,563
5 Reprocessor of Single Use Devices 15 2 17
6 U.S. Manufacturer of Export Only Devices 84 0 84
7 Repackager/Relabeler 1,210 293 1,503
8 Remanufacturer 48 51 99
9 Foreign Exporter 0 822 822
10 Initial Distributor/Importer 3,889   3,889
  Unknown 140 63 203
  Total: 11,770 8,479 20,249
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