Data / Medical devices / Sterilization Wrap Containers, Trays, Cassettes & Other Accessories / United States
FDA-registered makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories in the United States: 122 establishments
122 establishments in the United States are registered with the FDA to make Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT). 78 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.
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- Device
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Product code
- KCT
- Country
- United States
Makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Intuitive Surgical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Manufacturer for export | 13 | February 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aesculap, Inc. | Center Valley, PA, United States | Complaint file establishment, Specification developer | 12 | March 27, 2020 | 0 | 1 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 11 | August 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 10 | November 30, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 9 | July 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 9 | March 11, 2013 | 0 | 1 | 0 | api.fda.gov |
| Santa Barbara Imaging Systems | Goleta, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 8 | August 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Case Medical, Inc. | Bloomfield, NJ, United States | Manufacturer | 7 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Manufacturer for export, Specification developer | 7 | February 1, 2019 | 0 | 1 | 0 | api.fda.gov |
| Innovative Sterilization Techn | Dayton, OH, United States | Manufacturer | 6 | May 1, 2025 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer, Specification developer | 6 | January 5, 2011 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | March 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Cleveland, OH, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 5 | March 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Bahadir Usa LLC | Carneys Point, NJ, United States | Contract manufacturer, Manufacturer | 4 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Manufacturer, Specification developer | 4 | March 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 4 | March 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer, Manufacturer | 4 | June 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Specification developer | 3 | July 31, 2017 | 0 | 1 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 3 | March 28, 2014 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer, Specification developer | 3 | September 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | Marlborough, MA, United States | Complaint file establishment, Specification developer | 3 | February 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Implant Direct Sybron Manufacturing LLC | Thousand Oaks, CA, United States | Manufacturer | 3 | January 28, 2021 | 0 | 1 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | December 28, 2015 | 0 | 1 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 3 | March 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Amcor Flexibles, LLC | Mundelein, IL, United States | Contract manufacturer, Manufacturer | 2 | October 15, 2012 | 0 | 0 | 0 | api.fda.gov |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 2 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Crossroads Extremity Systems LLC | Memphis, TN, United States | Manufacturer | 2 | July 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 2 | February 21, 2013 | 0 | 0 | 0 | api.fda.gov |
| ConforMIS, Inc. | Wilmington, MA, United States | Specification developer | 2 | October 25, 2017 | 0 | 0 | 0 | api.fda.gov |
| ContainMed, Inc. | Indianapolis, IN, United States | Manufacturer, Repackager or relabeler | 2 | December 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Boulder, CO, United States | Manufacturer | 2 | July 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 2 | July 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| Grace Medical, Inc. | Memphis, TN, United States | Manufacturer | 2 | March 13, 2014 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 2 | August 2, 2004 | 0 | 0 | 0 | api.fda.gov |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 2 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer | 2 | October 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 2 | October 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Microline Surgical, Inc | Beverly, MA, United States | Complaint file establishment, Manufacturer | 2 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Neotract, Inc. | Pleasanton, CA, United States | Specification developer | 2 | October 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | January 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Symmetry Medical, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer, Manufacturer | 2 | October 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 2 | April 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Activ Surgical Inc | Boston, MA, United States | Complaint file establishment, Manufacturer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Assembly-Tek LLC | Dayton, OH, United States | Contract manufacturer, Repackager or relabeler | 1 | March 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Manufacturer, Specification developer | 1 | September 30, 2004 | 0 | 0 | 0 | api.fda.gov |
| Caldera Medical, Inc. | Westlake Village, CA, United States | Repackager or relabeler, Specification developer | 1 | July 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Crosstex International, Inc. | Sharon, PA, United States | Manufacturer | 1 | December 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Crosstex International | Rush, NY, United States | Repackager or relabeler, Specification developer | 1 | December 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 1 | February 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Enviropak LLC | Peachtree City, GA, United States | Manufacturer | 1 | July 13, 1993 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Manufacturer, Specification developer | 1 | August 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Peachtree Corners, GA, United States | Manufacturer for export, Repackager or relabeler | 1 | February 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Jewel Precision Sheet Metal & Machining, Inc. | Cedar Grove, NJ, United States | Manufacturer | 1 | December 9, 2016 | 0 | 2 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Kerr Corporation | Orange, CA, United States | Complaint file establishment, Specification developer | 1 | April 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Mastel Surgical Inc. | Rapid City, SD, United States | Manufacturer | 1 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Mastel Surgical Inc. | Schiller Park, IL, United States | Manufacturer | 1 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Navigation, Inc. | Lafayette, CO, United States | Repackager or relabeler, Specification developer | 1 | May 6, 1997 | 0 | 0 | 0 | api.fda.gov |
| NuVasive Specialized Orthopedics, Inc. | Audubon, PA, United States | Manufacturer | 1 | January 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Orthopli Corp. | Philadelphia, PA, United States | Specification developer | 1 | August 2, 2010 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer, Manufacturer for export | 1 | October 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Paragon Implant Company, LLC | Las Vegas, NV, United States | Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Paragon Implant MFG., LLC | Calabasas, CA, United States | Complaint file establishment, Manufacturer | 1 | November 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | March 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Pro-Dex, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Pro-Dex Inc | Tustin, CA, United States | Complaint file establishment, Manufacturer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Skeletal Dynamics, Inc | Miami, FL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | December 7, 2010 | 0 | 0 | 0 | api.fda.gov |
| Sterizign Precision Technologies | Brunswick, ME, United States | Complaint file establishment, Manufacturer | 1 | February 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Manufacturer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Repackager or relabeler, Specification developer | 1 | September 9, 2008 | 0 | 0 | 0 | api.fda.gov |
| SterCUBE Surgical Systems, LLC | Grapevine, TX, United States | Complaint file establishment, Specification developer | 1 | October 20, 2015 | 0 | 1 | 0 | api.fda.gov |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 1 | January 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Contract manufacturer, Manufacturer, Specification developer | 1 | April 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Tecomet, Inc. | Kenosha, WI, United States | Manufacturer | 1 | August 2, 2002 | 0 | 0 | 0 | api.fda.gov |
| Thompson Surgical Instruments, Inc. | Traverse City, MI, United States | Manufacturer, Specification developer | 1 | October 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | Manufacturer | 1 | October 15, 2019 | 0 | 0 | 0 | api.fda.gov |
| Vericel Corporation | Cambridge, MA, United States | Complaint file establishment, Specification developer | 1 | February 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Seabrook | Seabrook, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amcor Flexibles, Commerce | Commerce, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Empirical Spine, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabtech Precision Sheet Metal, LLC | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hand Biomechanics Lab, Inc. | Sacramento, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoosier Plastics Inc | Terre Haute, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Humphry's Industrial Products Inc | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideate Medical | Saint Louis, MO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insert Molding Solutions, Inc. | Cumming, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MBM Packaging Labs, Inc | Rogersville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medin Technologies, Inc. | Totowa, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicraft Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.H. Cross Enterprises, Inc. | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ram Precision Industries Inc | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Re:build Tekna, LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remington Medical, Inc. | Alpharetta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIMED, Inc. | Ridgeville, SC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stoll Metalcraft, Inc. | Santa Clarita, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supreme Screw Products | Plainview, NY, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TydenBrooks | Tallapoosa, GA, 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 | |
| Viant AS&O Holdings, LLC | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, 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.