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Data / Medical devices / Drape, Surgical, Antimicrobial / United States

FDA-registered makers of Drape, Surgical, Antimicrobial in the United States: 42 establishments

42 establishments in the United States are registered with the FDA to make Drape, Surgical, Antimicrobial (product code KKX). 34 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Drape, Surgical, Antimicrobial
Product code
KKX
Country
United States

Makers of Drape, Surgical, Antimicrobial in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Customed, Inc.Fajardo, PR, United StatesManufacturer, Repackager or relabeler20January 13, 2011042api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer9November 9, 2010010api.fda.gov
Intl. Medsurg Connection, Inc.Schaumburg, IL, United StatesSpecification developer6October 5, 2010000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler4March 16, 2006000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer3November 17, 2005000api.fda.gov
Trinity Sterile, Inc.Salisbury, MD, United StatesManufacturer3August 13, 1992000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler2November 17, 2005000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer2October 20, 1997000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2October 10, 2007020api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer2February 25, 19970100api.fda.gov
Pacon Manufacturing Company LLCNavassa, NC, United StatesContract manufacturer, Manufacturer2March 15, 1986000api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer2May 18, 2023000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer2February 26, 1998000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer2May 18, 2023000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer2May 18, 2023000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2October 10, 2007000api.fda.gov
WestBridge Vocational, Inc.Sylva, NC, United StatesContract manufacturer, Manufacturer2April 27, 2005000api.fda.gov
Angiosystems, Inc.Ducktown, TN, United StatesManufacturer1September 21, 1984000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer1April 11, 1994000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer, Repackager or relabeler1April 11, 1994000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesSpecification developer1March 12, 2001000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer1September 22, 2009000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Repackager or relabeler1March 12, 2014000api.fda.gov
Flex Operating Room, IncFarmington, NY, United StatesSpecification developer1October 4, 2010000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer1August 17, 2000000api.fda.gov
Haywood Vocational Opportunities Inc.Waynesville, NC, United StatesContract manufacturer, Manufacturer1April 27, 2005000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer1May 17, 2005010api.fda.gov
Microsurgical Technology, Inc.Redmond, WA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1May 17, 2005000api.fda.gov
Mid Central MedicalSaint Vincent, MN, United StatesSpecification developer1September 20, 2010000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer1February 21, 1985000api.fda.gov
Qsum Biopsy Disposables LLCPequot Lakes, MN, United StatesComplaint file establishment, Specification developer1February 25, 1997000api.fda.gov
Radscan Medical Equipment, Inc.Phoenix, AZ, United StatesSpecification developer1January 4, 2011000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer1December 1, 2005010api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer1December 1, 2005000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Foothills Industries, Inc.Marion, NC, United StatesContract manufacturer0000api.fda.gov
Midwest Sterilization Corp.Laredo, TX, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
PMT Corp.Chanhassen, MN, United StatesManufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Surgentec LLCBoca Raton, FL, United StatesManufacturer0000api.fda.gov
WeslacovaNorth Wilkesboro, NC, United StatesContract manufacturer0000api.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.