Data / Medical devices / Pessary, Vaginal
Pessary, Vaginal (HHW): 25 FDA-registered makers in 8 countries
25 establishments in 8 countries are registered with the FDA to make Pessary, Vaginal (product code HHW, Class 2, 21 CFR 884.3575). 15 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on January 20, 2026, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HHW
- Device class
- 2
- Regulation
- 884.3575
- Medical specialty
- Obstetrics/Gynecology
Makers by country
| Country | Makers |
|---|---|
| United States | 12 |
| Canada | 4 |
| China | 3 |
| Taiwan | 2 |
| Israel | 1 |
| Costa Rica | 1 |
| Hong Kong | 1 |
| Mexico | 1 |
Makers of Pessary, Vaginal
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 | Complaint file establishment, Manufacturer, Specification developer | 4 | April 11, 2025 | 0 | 6 | 0 | api.fda.gov |
| Bioteque Taiwan Ltd. | Xizhi Dist., New Taipei City, Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 3 | October 31, 2018 | 0 | 0 | 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 |
| Resilia Inc. | Moncton New Brunswick, Canada | Complaint file establishment, Specification developer | 2 | April 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Bioteque America, Inc. | Richardson, TX, United States | Manufacturer | 1 | December 27, 2001 | 0 | 0 | 0 | api.fda.gov |
| CNTRL+ Inc. | Cornwall Ontario, Canada | Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Contipi Medical Ltd | Caesarea Haifa, Israel | Specification developer | 1 | July 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Cosm Medical | Toronto Ontario, Canada | Complaint file establishment, Manufacturer | 1 | March 6, 2024 | 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 |
| Li Medical Corporation Ltd. | New Taipei City, Taiwan | Foreign private label distributor, Manufacturer | 1 | November 18, 2003 | 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 | |
| B&a Precision Silicone Rubber (dongguan) Co., Ltd | Dongguan Guangdong, China | Contract 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 | |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Sterling Industries Ltd. | Woodbridge Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing Ltd. | HENG LI, DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Medical Equipment Manufacturing, Ltd. | Kwai Chung, N.T., Hong Kong | 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 | |
| Via Systems Manufacturas | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 20, 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.