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Data / Medical devices / Cover, Shoe, Operating-Room / United States

FDA-registered makers of Cover, Shoe, Operating-Room in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Cover, Shoe, Operating-Room (product code FXP). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.

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Device
Cover, Shoe, Operating-Room
Product code
FXP
Country
United States

Makers of Cover, Shoe, Operating-Room in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer1January 29, 1993000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesManufacturer, Specification developer0000api.fda.gov
Anzen HealthChicago, IL, United StatesSpecification developer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer0000api.fda.gov
Apex Aseptic ProductsVoorhees, NJ, United StatesSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Casco Manufacturing Solutions, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Cellucap Manufacturing Co.Phila, PA, United StatesSpecification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
HPK IndustriesFrankfort, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Janin Group, Inc.Waco, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Laguna ScientificAliso Viejo, CA, United StatesSpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Safesource DirectBroussard, LA, United StatesManufacturer0000api.fda.gov
Sloan MedicalOmaha, NE, United StatesManufacturer, Specification developer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
Two One Two New York, Inc.Edgewood, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Vonco Products, LLCTrevor, WI, United StatesContract manufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.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.