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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 25 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Halyard North Carolina, LLC | Linwood, NC, United States | Manufacturer | 19 | July 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 16 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Repackager or relabeler, Specification developer | 11 | October 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Case Medical, Inc. | Bloomfield, NJ, United States | Manufacturer | 9 | February 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Andersen Sterilizers, Inc. | Haw River, NC, United States | Specification developer | 6 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ahlstrom Nonwovens LLC | Windsor Locks, CT, United States | Manufacturer | 4 | December 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Specification developer | 3 | December 19, 2014 | 0 | 2 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 3 | August 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Ready Set Import | Beverly Hills, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | February 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Standard Textile Co., Inc. | Cincinnati, OH, United States | Specification developer | 3 | August 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 2 | December 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | October 16, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Repackager or relabeler, Specification developer | 2 | December 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 2 | August 20, 2002 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Cleveland, OH, United States | Manufacturer, Repackager or relabeler | 2 | August 20, 2002 | 0 | 0 | 0 | api.fda.gov |
| Amcor Flexibles, LLC | Mundelein, IL, United States | Contract manufacturer, Manufacturer | 1 | June 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 1 | February 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| Amcor Flexibles, Commerce | Commerce, CA, United States | Contract manufacturer, Manufacturer | 1 | June 2, 1983 | 0 | 0 | 0 | api.fda.gov |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Manufacturer | 1 | January 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer, Repackager or relabeler | 1 | December 16, 1993 | 0 | 0 | 0 | api.fda.gov |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Manufacturer | 1 | January 14, 1999 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Fox Converting, Inc. | Green Bay, WI, United States | Manufacturer | 1 | October 26, 1982 | 0 | 0 | 0 | api.fda.gov |
| Icp, Inc. | Green Bay, WI, United States | Specification developer | 1 | April 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 1 | January 10, 1990 | 0 | 0 | 0 | api.fda.gov |
| Nucare LLC | Montclair, CA, United States | Specification developer | 1 | August 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Specification developer | 1 | November 13, 1997 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 1 | December 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 1 | December 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| STERIMED, Inc. | Ridgeville, SC, United States | Manufacturer | 1 | December 16, 1993 | 0 | 0 | 0 | api.fda.gov |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer, Manufacturer | 1 | December 7, 2001 | 0 | 0 | 0 | api.fda.gov |
| Tidi Products, LLC | Neenah, WI, United States | Manufacturer | 1 | November 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| TURBETT SURGICAL, Inc | Macedon, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 14, 2016 | 0 | 3 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Battech | Irvine, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPAC Equipment, Inc. | Leicester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enviropak LLC | Peachtree City, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Mold Tool, Inc. | Pittsfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M & Q Packaging LLC | Schuylkill Haven, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Propper MFG. Co., Inc. | Long Island City, NY, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Medical Enterprise, Inc. | Thomson, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.