Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Intuitive Surgical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Manufacturer for export13February 1, 2019000api.fda.gov
Aesculap, Inc.Center Valley, PA, United StatesComplaint file establishment, Specification developer12March 27, 2020010api.fda.gov
Steris CorporationMentor, OH, United StatesComplaint file establishment, Repackager or relabeler, Specification developer11August 7, 2023000api.fda.gov
Summit Medical LLCSaint Paul, MN, United StatesManufacturer10November 30, 2021000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer9July 5, 2013000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer9March 11, 2013010api.fda.gov
Santa Barbara Imaging SystemsGoleta, CA, United StatesManufacturer, Repackager or relabeler, Specification developer8August 18, 2015000api.fda.gov
Case Medical, Inc.Bloomfield, NJ, United StatesManufacturer7June 3, 2026000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesManufacturer for export, Specification developer7February 1, 2019010api.fda.gov
Innovative Sterilization TechnDayton, OH, United StatesManufacturer6May 1, 2025010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer6January 5, 2011000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Specification developer5March 21, 2016000api.fda.gov
STERIS CorporationCleveland, OH, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5March 21, 2016000api.fda.gov
Bahadir Usa LLCCarneys Point, NJ, United StatesContract manufacturer, Manufacturer4March 22, 2024000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer4March 31, 2016000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4March 22, 2024000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer, Manufacturer4June 13, 2019000api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Specification developer3July 31, 2017010api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer3March 28, 2014000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer, Specification developer3September 7, 2016000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer3February 26, 2019000api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer3January 28, 2021010api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3December 28, 2015010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer3March 28, 2025000api.fda.gov
Amcor Flexibles, LLCMundelein, IL, United StatesContract manufacturer, Manufacturer2October 15, 2012000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer2August 6, 2020000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesManufacturer2July 16, 2024000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer2February 21, 2013000api.fda.gov
ConforMIS, Inc.Wilmington, MA, United StatesSpecification developer2October 25, 2017000api.fda.gov
ContainMed, Inc.Indianapolis, IN, United StatesManufacturer, Repackager or relabeler2December 12, 2023000api.fda.gov
CovidienBoulder, CO, United StatesManufacturer2July 17, 2018000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2July 17, 2018000api.fda.gov
Grace Medical, Inc.Memphis, TN, United StatesManufacturer2March 13, 2014000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer2August 2, 2004000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler2August 6, 2020000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer2October 15, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer2October 15, 2019000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2June 20, 2025000api.fda.gov
Microline Surgical, IncBeverly, MA, United StatesComplaint file establishment, Manufacturer2May 12, 2016000api.fda.gov
Neotract, Inc.Pleasanton, CA, United StatesSpecification developer2October 22, 2021000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2January 25, 2016000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer, Manufacturer2October 22, 2004000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler2April 14, 2020000api.fda.gov
Activ Surgical IncBoston, MA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Assembly-Tek LLCDayton, OH, United StatesContract manufacturer, Repackager or relabeler1March 13, 2006000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesManufacturer, Specification developer1September 30, 2004000api.fda.gov
Caldera Medical, Inc.Westlake Village, CA, United StatesRepackager or relabeler, Specification developer1July 20, 2020000api.fda.gov
Crosstex International, Inc.Sharon, PA, United StatesManufacturer1December 22, 1994000api.fda.gov
Crosstex InternationalRush, NY, United StatesRepackager or relabeler, Specification developer1December 22, 1994000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer1February 26, 2026000api.fda.gov
Enviropak LLCPeachtree City, GA, United StatesManufacturer1July 13, 1993000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer1August 2, 2010000api.fda.gov
Intuitive Surgical, Inc.Peachtree Corners, GA, United StatesManufacturer for export, Repackager or relabeler1February 1, 2019000api.fda.gov
Jewel Precision Sheet Metal & Machining, Inc.Cedar Grove, NJ, United StatesManufacturer1December 9, 2016020api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer1August 2, 2002000api.fda.gov
Kerr CorporationOrange, CA, United StatesComplaint file establishment, Specification developer1April 21, 2017000api.fda.gov
Mastel Surgical Inc.Rapid City, SD, United StatesManufacturer1June 18, 2026000api.fda.gov
Mastel Surgical Inc.Schiller Park, IL, United StatesManufacturer1June 18, 2026000api.fda.gov
Medtronic Navigation, Inc.Lafayette, CO, United StatesRepackager or relabeler, Specification developer1May 6, 1997000api.fda.gov
NuVasive Specialized Orthopedics, Inc.Audubon, PA, United StatesManufacturer1January 25, 2016000api.fda.gov
Orthopli Corp.Philadelphia, PA, United StatesSpecification developer1August 2, 2010000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer, Manufacturer for export1October 29, 2020000api.fda.gov
Paragon Implant Company, LLCLas Vegas, NV, United StatesManufacturer1November 14, 2025000api.fda.gov
Paragon Implant MFG., LLCCalabasas, CA, United StatesComplaint file establishment, Manufacturer1November 14, 2025000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1March 21, 2025000api.fda.gov
Pro-Dex, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Pro-Dex IncTustin, CA, United StatesComplaint file establishment, Manufacturer1August 2, 2002000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1December 7, 2010000api.fda.gov
Sterizign Precision TechnologiesBrunswick, ME, United StatesComplaint file establishment, Manufacturer1February 7, 2018000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesManufacturer1August 2, 2002000api.fda.gov
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)Birmingham, AL, United StatesRepackager or relabeler, Specification developer1September 9, 2008000api.fda.gov
SterCUBE Surgical Systems, LLCGrapevine, TX, United StatesComplaint file establishment, Specification developer1October 20, 2015010api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1January 16, 2025000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesContract manufacturer, Manufacturer, Specification developer1April 14, 1977000api.fda.gov
Tecomet, Inc.Kenosha, WI, United StatesManufacturer1August 2, 2002000api.fda.gov
Thompson Surgical Instruments, Inc.Traverse City, MI, United StatesManufacturer, Specification developer1October 16, 2015000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer1October 15, 2019000api.fda.gov
Vericel CorporationCambridge, MA, United StatesComplaint file establishment, Specification developer1February 7, 2018000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Amcor Flexibles, CommerceCommerce, CA, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Empirical Spine, Inc.Morgan Hill, CA, United StatesManufacturer0000api.fda.gov
Fabtech Precision Sheet Metal, LLCSpokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Hand Biomechanics Lab, Inc.Sacramento, CA, United StatesManufacturer0000api.fda.gov
Hoosier Plastics IncTerre Haute, IN, United StatesContract manufacturer0000api.fda.gov
Humphry's Industrial Products IncRochester, NH, United StatesContract manufacturer0000api.fda.gov
Ideate MedicalSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Insert Molding Solutions, Inc.Cumming, GA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
MBM Packaging Labs, IncRogersville, TN, United StatesContract manufacturer0000api.fda.gov
Medin Technologies, Inc.Totowa, NJ, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Medicraft IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.H. Cross Enterprises, Inc.Portage, MI, United StatesContract manufacturer0000api.fda.gov
Ram Precision Industries IncDayton, OH, United StatesContract manufacturer0000api.fda.gov
Re:build Tekna, LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Remington Medical, Inc.Alpharetta, GA, United StatesContract manufacturer0000api.fda.gov
STERIMED, Inc.Ridgeville, SC, United StatesContract manufacturer0000api.fda.gov
Stoll Metalcraft, Inc.Santa Clarita, CA, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Supreme Screw ProductsPlainview, NY, United StatesManufacturer for export0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
TydenBrooksTallapoosa, GA, United StatesContract manufacturer0000api.fda.gov
United Medical Enterprise, Inc.Thomson, GA, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, 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.