Data / Medical devices / Pessary, Vaginal / United States
FDA-registered makers of Pessary, Vaginal in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Pessary, Vaginal (product code HHW). 9 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Pessary, Vaginal
- Product code
- HHW
- Country
- United States
Makers of Pessary, Vaginal in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | Trumbull, CT, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | April 11, 2025 | 0 | 6 | 0 | api.fda.gov |
| Medgyn Products, Inc. | Westmont, IL, United States | Manufacturer, Repackager or relabeler | 2 | December 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Bioteque America, Inc. | Richardson, TX, United States | Manufacturer | 1 | December 27, 2001 | 0 | 0 | 0 | api.fda.gov |
| Kimberly-Clark Corporation | Neenah, WI, United States | Complaint file establishment, Specification developer | 1 | August 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| Personal Medical Corp. | Bothell, WA, United States | Complaint file establishment, Specification developer | 1 | December 13, 1999 | 0 | 0 | 0 | api.fda.gov |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 1 | November 18, 2003 | 0 | 0 | 0 | api.fda.gov |
| Reia, LLC | Portland, ME, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | May 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rinovum Subsidiary 2, LLC | Export, PA, United States | Complaint file establishment, Specification developer | 1 | January 25, 2019 | 0 | 1 | 0 | api.fda.gov |
| Watkins-Conti Products, Inc | Edmond, OK, United States | Specification developer | 1 | May 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| A&m Biomedical Inc. | Laguna Hills, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.