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.
| RANK | ESTABLISHMENT_TYPE | DOMESTIC | FOREIGN | TOTAL |
|---|---|---|---|---|
| 1 | Manufacturer | 4934 | 6709 | 11,643 |
| 2 | Contract Manufacturer | 311 | 639 | 950 |
| 3 | Contract Sterilizer | 16 | 42 | 58 |
| 4 | Specification Developer | 1364 | 290 | 1,654 |
| 5 | Reprocessor of Single Use Devices | 16 | 3 | 19 |
| 6 | U.S. Manufacturer of Export Only Devices | 92 | 0 | 92 |
| 7 | Repackager/Relabeler | 1339 | 337 | 1,676 |
| 8 | Remanufacturer | 52 | 57 | 109 |
| 9 | Foreign Exporter | 0 | 913 | 913 |
| 10 | Initial Distributor/Importer | 4,233 | 0 | 4,233 |
| Unknown | 140 | 65 | 205 | |
| Total: | 12,497 | 9,055 | 21,552 |
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