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Data / Medical devices / Speculum, Vaginal, Nonmetal / United States

FDA-registered makers of Speculum, Vaginal, Nonmetal in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Speculum, Vaginal, Nonmetal (product code HIB). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Speculum, Vaginal, Nonmetal
Product code
HIB
Country
United States

Makers of Speculum, Vaginal, Nonmetal in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4September 9, 2009020api.fda.gov
Medgyn Products, Inc.Westmont, IL, United StatesManufacturer, Repackager or relabeler2September 15, 2011000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer1April 21, 1994000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesRepackager or relabeler, Specification developer1July 11, 2005000api.fda.gov
Impact Innovations LLCBoca Raton, FL, United StatesSpecification developer1August 6, 2013000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1February 8, 2008000api.fda.gov
OBP Medical CorporationLawrence, MA, United StatesSpecification developer1September 9, 2009010api.fda.gov
Alliance Precision PlasticsGates, NY, United StatesContract manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Ceek Women's HealthPortland, OR, United StatesSpecification developer0000api.fda.gov
Global Plastics, Inc.Indianapolis, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
My Village InnovationsEncinitas, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tessy Plastics Corp.Elbridge, NY, United StatesContract manufacturer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesManufacturer, Specification developer0010api.fda.gov
Weco Manufacturing Group-HenriettaRochester, NY, United StatesManufacturer, Repackager or relabeler0000api.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.