Data / Medical devices / System, X-Ray, Mammographic / United States
FDA-registered makers of System, X-Ray, Mammographic in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make System, X-Ray, Mammographic (product code IZH). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.
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- Device
- System, X-Ray, Mammographic
- Product code
- IZH
- Country
- United States
Makers of System, X-Ray, Mammographic in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hologic, Inc. | Newark, DE, United States | Complaint file establishment, Manufacturer | 11 | October 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Macbrud Corp., Medical Division | Crossings, FL, United States | Manufacturer | 2 | January 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| BD Puerto Rico LLC | Juncos, PR, United States | Manufacturer | 1 | September 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Becton Dickinson | Franklin Lakes, NJ, United States | Specification developer | 1 | September 14, 1988 | 0 | 0 | 0 | api.fda.gov |
| Beekley Corporation | Bristol, CT, United States | Manufacturer | 1 | March 26, 2008 | 0 | 1 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | November 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| Remington Medical, Inc. | Alpharetta, GA, United States | Manufacturer | 1 | November 3, 1998 | 0 | 0 | 0 | api.fda.gov |
| Dion Label Printing, Inc. | Westfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UFP Technologies, Inc. | Compton, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. 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.