Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
HHW
Device class
2
Regulation
884.3575
Medical specialty
Obstetrics/Gynecology

Makers by country

CountryMakers
United States12
Canada4
China3
Taiwan2
Israel1
Costa Rica1
Hong Kong1
Mexico1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Manufacturer, Specification developer4April 11, 2025060api.fda.gov
Bioteque Taiwan Ltd.Xizhi Dist., New Taipei City, TaiwanContract manufacturer, Exporter to the US, Manufacturer3October 31, 2018000api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer, Repackager or relabeler2December 5, 2014000api.fda.gov
Resilia Inc.Moncton New Brunswick, CanadaComplaint file establishment, Specification developer2April 3, 2024000api.fda.gov
Bioteque America, Inc.Richardson, TX, United StatesManufacturer1December 27, 2001000api.fda.gov
CNTRL+ Inc.Cornwall Ontario, CanadaManufacturer1December 17, 2024000api.fda.gov
Contipi Medical LtdCaesarea Haifa, IsraelSpecification developer1July 8, 2019000api.fda.gov
Cosm MedicalToronto Ontario, CanadaComplaint file establishment, Manufacturer1March 6, 2024000api.fda.gov
Kimberly-Clark CorporationNeenah, WI, United StatesComplaint file establishment, Specification developer1August 27, 2013000api.fda.gov
Li Medical Corporation Ltd.New Taipei City, TaiwanForeign private label distributor, Manufacturer1November 18, 2003000api.fda.gov
Personal Medical Corp.Bothell, WA, United StatesComplaint file establishment, Specification developer1December 13, 1999000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer1November 18, 2003000api.fda.gov
Reia, LLCPortland, ME, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1May 21, 2024000api.fda.gov
Rinovum Subsidiary 2, LLCExport, PA, United StatesComplaint file establishment, Specification developer1January 25, 2019010api.fda.gov
Watkins-Conti Products, IncEdmond, OK, United StatesSpecification developer1May 17, 2024000api.fda.gov
A&m Biomedical Inc.Laguna Hills, CA, United StatesContract manufacturer0000api.fda.gov
B&a Precision Silicone Rubber (dongguan) Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Cooper Medical, SRLLa Garita Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Guangzhou Fame Medical Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
J. Sterling Industries Ltd.Woodbridge Ontario, CanadaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing Ltd.HENG LI, DONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.Kwai Chung, N.T., Hong KongContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Via Systems ManufacturasTijuana Baja California, MexicoContract manufacturer0000api.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.