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Data / Medical devices / Wrap, Sterilization / United States

FDA-registered makers of Wrap, Sterilization in the United States: 48 establishments

48 establishments in the United States are registered with the FDA to make Wrap, Sterilization (product code FRG). 34 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Wrap, Sterilization
Product code
FRG
Country
United States

Makers of Wrap, Sterilization in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer25July 2, 2026000api.fda.gov
Halyard North Carolina, LLCLinwood, NC, United StatesManufacturer19July 2, 2026000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer16February 21, 2025000api.fda.gov
Steris CorporationMentor, OH, United StatesRepackager or relabeler, Specification developer11October 16, 2024000api.fda.gov
Case Medical, Inc.Bloomfield, NJ, United StatesManufacturer9February 10, 2017000api.fda.gov
Andersen Sterilizers, Inc.Haw River, NC, United StatesSpecification developer6November 12, 2020000api.fda.gov
Ahlstrom Nonwovens LLCWindsor Locks, CT, United StatesManufacturer4December 7, 2023000api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Specification developer3December 19, 2014020api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer3August 8, 2012000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3February 13, 2023000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer3August 25, 2017000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer2December 11, 2018000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Repackager or relabeler, Specification developer2October 16, 2006000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesRepackager or relabeler, Specification developer2December 5, 2008000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Specification developer2August 20, 2002000api.fda.gov
STERIS CorporationCleveland, OH, United StatesManufacturer, Repackager or relabeler2August 20, 2002000api.fda.gov
Amcor Flexibles, LLCMundelein, IL, United StatesContract manufacturer, Manufacturer1June 6, 2011000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer1February 15, 2006000api.fda.gov
Amcor Flexibles, CommerceCommerce, CA, United StatesContract manufacturer, Manufacturer1June 2, 1983000api.fda.gov
Brasseler U.S.A. Dental, LLCSavannah, GA, United StatesManufacturer1January 14, 1999000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer, Repackager or relabeler1December 16, 1993000api.fda.gov
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesManufacturer1January 14, 1999000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer1April 28, 2017000api.fda.gov
Fox Converting, Inc.Green Bay, WI, United StatesManufacturer1October 26, 1982000api.fda.gov
Icp, Inc.Green Bay, WI, United StatesSpecification developer1April 28, 2017000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer1January 10, 1990000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer1August 3, 2018000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer1November 13, 1997000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1December 7, 2001000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1December 7, 2001000api.fda.gov
STERIMED, Inc.Ridgeville, SC, United StatesManufacturer1December 16, 1993000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer, Manufacturer1December 7, 2001000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer1November 17, 2004000api.fda.gov
TURBETT SURGICAL, IncMacedon, NY, United StatesComplaint file establishment, Manufacturer, Specification developer1January 14, 2016030api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
BattechIrvine, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
CPAC Equipment, Inc.Leicester, NY, United StatesContract manufacturer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Enviropak LLCPeachtree City, GA, United StatesManufacturer0000api.fda.gov
Hi-Tech Mold Tool, Inc.Pittsfield, MA, United StatesContract manufacturer0000api.fda.gov
M & Q Packaging LLCSchuylkill Haven, PA, United StatesManufacturer0000api.fda.gov
Propper MFG. Co., Inc.Long Island City, NY, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
United Medical Enterprise, Inc.Thomson, GA, United StatesContract manufacturer0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Viant AS&O Holdings, LLCIndianapolis, IN, 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.