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Data / Medical devices / Indicator, Physical/Chemical Sterilization Process / United States

FDA-registered makers of Indicator, Physical/Chemical Sterilization Process in the United States: 33 establishments

33 establishments in the United States are registered with the FDA to make Indicator, Physical/Chemical Sterilization Process (product code JOJ). 23 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
Indicator, Physical/Chemical Sterilization Process
Product code
JOJ
Country
United States

Makers of Indicator, Physical/Chemical Sterilization Process in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
STERIS CorporationMentor, OH, United StatesContract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler22April 25, 2025010api.fda.gov
Steritec Products MFG. Co., Inc.Englewood, CO, United StatesComplaint file establishment, Manufacturer17February 20, 2025020api.fda.gov
Crosstex InternationalRush, NY, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer15January 21, 2022000api.fda.gov
Propper MFG. Co., Inc.Long Island City, NY, United StatesManufacturer, Repackager or relabeler13June 12, 2024010api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer9July 5, 2024030api.fda.gov
Solventum Us LLCEagan, MN, United StatesComplaint file establishment, Specification developer9September 23, 2022000api.fda.gov
STERIS CorporationFranklin Park, IL, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export9April 25, 2025000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Manufacturer, Specification developer9September 23, 2022000api.fda.gov
Steris CorporationMentor, OH, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer8August 20, 2024000api.fda.gov
Hu-Friedy MFG. Co. LLCNorthbrook, IL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer7January 21, 2022000api.fda.gov
Mesa Laboratories Bozeman Manufacturing Facility (Zoot)Bozeman, MT, United StatesComplaint file establishment, Repackager or relabeler, Specification developer6May 12, 2016000api.fda.gov
Solventum US LLCFlemington, NJ, United StatesManufacturer6June 24, 2022000api.fda.gov
Andersen Sterilizers, Inc.Haw River, NC, United StatesManufacturer5November 12, 2020000api.fda.gov
Medivators IncMinneapolis, MN, United StatesManufacturer for export, Specification developer4May 2, 2025000api.fda.gov
Serim Research Corp.Elkhart, IN, United StatesManufacturer, Manufacturer for export4October 12, 2012000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer2April 15, 2011000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer2September 23, 2022000api.fda.gov
True Indicating LLCToledo, OH, United StatesManufacturer, Repackager or relabeler2January 17, 2025000api.fda.gov
Case Medical, Inc.Bloomfield, NJ, United StatesManufacturer1February 9, 1999000api.fda.gov
CS Medical LLCCreedmoor, NC, United StatesManufacturer, Specification developer1April 2, 2020000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer1May 7, 2002000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer1December 17, 2024000api.fda.gov
Indilab, Inc.Franklin Park, IL, United StatesContract manufacturer, Manufacturer1March 31, 1988000api.fda.gov
Amcor Flexibles, LLCMundelein, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
BattechIrvine, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Coast Pneumatics, Inc.Anaheim, CA, United StatesContract manufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer0000api.fda.gov
Hi-Tech Products Inc.Buena Park, CA, United StatesContract manufacturer0000api.fda.gov
IBT ScientificCreedmoor, NC, United StatesContract manufacturer0000api.fda.gov
Icp, Inc.Green Bay, WI, United StatesSpecification developer0000api.fda.gov
Kem Medical Products Corp.Hauppauge, NY, United StatesManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Weiman Products, LLCGurnee, IL, 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.