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

Indicator, Physical/Chemical Sterilization Process (JOJ): 70 FDA-registered makers in 17 countries

70 establishments in 17 countries are registered with the FDA to make Indicator, Physical/Chemical Sterilization Process (product code JOJ, Class 2, 21 CFR 880.2800). 35 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 266 510(k) clearances under this code, the latest on October 16, 2026, and lists 17 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JOJ
Device class
2
Regulation
880.2800
Medical specialty
General Hospital

Makers by country

CountryMakers
United States33
China15
Taiwan4
Canada3
United Kingdom2
Mexico2
Germany1
Turkey1
Australia1
Argentina1
Israel1
Japan1
Thailand1
South Korea1
Vietnam1
Malaysia1
France1

Makers of Indicator, Physical/Chemical Sterilization Process

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Albert Browne Ltd.Leicester, United KingdomComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer26December 4, 2024010api.fda.gov
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
Intertape Polymer Inc.Cornwall Ontario, CanadaManufacturer3August 2, 2019000api.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
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1August 7, 1989000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer1February 22, 2018000api.fda.gov
Anhui Ares Medical Technology Co.,ltd.Tianchang Anhui, ChinaContract manufacturer, Manufacturer1December 17, 2024000api.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
Dort-A Tip Malz San Ith Ihr Tic Ltd StiAnkara, TurkeyManufacturer1June 12, 2024000api.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
Jiangmen New Era External Drug Use Co., Ltd.Jiangmen Guangdong, ChinaExporter to the US, Manufacturer1December 17, 2024000api.fda.gov
Lantor (uk), Ltd.BOLTON North Yorkshire, United KingdomManufacturer1October 6, 1988000api.fda.gov
Nanosonics LimitedMacquarie Park New South Wales, AustraliaComplaint file establishment, Specification developer1March 3, 2011000api.fda.gov
Terragene SAAlvear Santa Fe, ArgentinaManufacturer1June 30, 2020010api.fda.gov
Tuttnauer Ltd.BEIT SHEMESH Jerusalem, IsraelSpecification developer1June 30, 2020000api.fda.gov
Weihai Xingtai Packaging Products Co., Ltd.WeiHai Shandong, ChinaExporter to the US, Manufacturer1December 17, 2024000api.fda.gov
3M Canada CompanyBrockville Ontario, CanadaContract manufacturer0000api.fda.gov
Amcor Flexibles, LLCMundelein, IL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
BattechIrvine, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Benq Materials Corp. Yunlin Factory 3Douliu City Yunlin, TaiwanContract manufacturer0000api.fda.gov
Coast Pneumatics, Inc.Anaheim, CA, United StatesContract manufacturer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer0000api.fda.gov
Dongguan Safesecure Medical Packaging Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Fomed Industries IncQian Jiang Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guangdong Maidi Medical Co.,ltdQingyuan Guangdong, ChinaManufacturer0000api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.La Mesa, Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Hi-Tech Products Inc.Buena Park, CA, United StatesContract manufacturer0000api.fda.gov
Hogy Medical Co., Ltd.INASHIKI-GUN Ibaraki, JapanContract manufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaContract manufacturer0000api.fda.gov
IBT ScientificCreedmoor, NC, United StatesContract manufacturer0000api.fda.gov
Icp, Inc.Green Bay, WI, United StatesSpecification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Jsongmed Medical Material Co.,ltdjiangsu, ChinaContract manufacturer0000api.fda.gov
Kem Medical Products Corp.Hauppauge, NY, United StatesManufacturer0000api.fda.gov
Medicom Asia-Pacific Holdings Limited. Taiwan BranchWujie Township Yilan, TaiwanComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Medicom Healthcare (Thailand) Co., Ltd.Tambol Nong Yai Chon Buri, ThailandContract manufacturer0000api.fda.gov
Plasmapp Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer, Repackager or relabeler0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Safesecure Medical Packaging Company LimitedHai Phong City, VietnamManufacturer0000api.fda.gov
Shanghai Jianzhong Medical Packaging Co., Ltd.Shanghai, ChinaContract manufacturer, Specification developer0000api.fda.gov
Sigma Medical Supplies Corp.Gueishan Taoyuan, TaiwanSpecification developer0000api.fda.gov
SMP Medtech Sdn. Bhd.Nilai Negeri Sembilan, MalaysiaContract manufacturer0000api.fda.gov
SPS MedicalCOULOMMIERS Seine-et-Marne, FranceContract manufacturer0000api.fda.gov
Sterileright Packaging MFG Inc.Keelung, TaiwanManufacturer0000api.fda.gov
Sterivic Medical Co.,ltd.ChiZhou Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen SafeSecure Medical Infection Control Tech Co., LtdShenzhen City Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Tianchang Jiarui Packaging Material Co., Ltd.Tianchang Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Weiman Products, LLCGurnee, IL, United StatesContract manufacturer0000api.fda.gov
Wellmed Dental Medical Supply Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov

Updated October 16, 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.