Data / Medical devices / Cannula, Intrauterine Insemination
Cannula, Intrauterine Insemination (MFD): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Cannula, Intrauterine Insemination (product code MFD, Class 2, 21 CFR 884.5250). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on July 16, 2002, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MFD
- Device class
- 2
- Regulation
- 884.5250
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 1 |
| India | 1 |
| Costa Rica | 1 |
Makers of Cannula, Intrauterine Insemination
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer | 5 | October 11, 2001 | 0 | 1 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 2 | December 19, 1995 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Spencer, IN, United States | Manufacturer | 2 | December 19, 1995 | 0 | 0 | 0 | api.fda.gov |
| Rocket Medical Plc | WASHINGTON Sunderland, United Kingdom | Manufacturer | 1 | March 2, 1998 | 0 | 0 | 0 | api.fda.gov |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices Pvt. Ltd. | Surat Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cooper Medical, SRL | La Garita Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 16, 2002. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.