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.
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.
- Product code
- JOJ
- Device class
- 2
- Regulation
- 880.2800
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 33 |
| China | 15 |
| Taiwan | 4 |
| Canada | 3 |
| United Kingdom | 2 |
| Mexico | 2 |
| Germany | 1 |
| Turkey | 1 |
| Australia | 1 |
| Argentina | 1 |
| Israel | 1 |
| Japan | 1 |
| Thailand | 1 |
| South Korea | 1 |
| Vietnam | 1 |
| Malaysia | 1 |
| France | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Albert Browne Ltd. | Leicester, United Kingdom | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | 26 | December 4, 2024 | 0 | 1 | 0 | api.fda.gov |
| STERIS Corporation | Mentor, OH, United States | Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler | 22 | April 25, 2025 | 0 | 1 | 0 | api.fda.gov |
| Steritec Products MFG. Co., Inc. | Englewood, CO, United States | Complaint file establishment, Manufacturer | 17 | February 20, 2025 | 0 | 2 | 0 | api.fda.gov |
| Crosstex International | Rush, NY, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 15 | January 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Propper MFG. Co., Inc. | Long Island City, NY, United States | Manufacturer, Repackager or relabeler | 13 | June 12, 2024 | 0 | 1 | 0 | api.fda.gov |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 9 | July 5, 2024 | 0 | 3 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Complaint file establishment, Specification developer | 9 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| STERIS Corporation | Franklin Park, IL, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export | 9 | April 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 9 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer | 8 | August 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hu-Friedy MFG. Co. LLC | Northbrook, IL, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 7 | January 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mesa Laboratories Bozeman Manufacturing Facility (Zoot) | Bozeman, MT, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 6 | May 12, 2016 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Flemington, NJ, United States | Manufacturer | 6 | June 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Andersen Sterilizers, Inc. | Haw River, NC, United States | Manufacturer | 5 | November 12, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medivators Inc | Minneapolis, MN, United States | Manufacturer for export, Specification developer | 4 | May 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Serim Research Corp. | Elkhart, IN, United States | Manufacturer, Manufacturer for export | 4 | October 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Intertape Polymer Inc. | Cornwall Ontario, Canada | Manufacturer | 3 | August 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 2 | April 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 2 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| True Indicating LLC | Toledo, OH, United States | Manufacturer, Repackager or relabeler | 2 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | August 7, 1989 | 0 | 0 | 0 | api.fda.gov |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Foreign private label distributor, Specification developer | 1 | February 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Anhui Ares Medical Technology Co.,ltd. | Tianchang Anhui, China | Contract manufacturer, Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Case Medical, Inc. | Bloomfield, NJ, United States | Manufacturer | 1 | February 9, 1999 | 0 | 0 | 0 | api.fda.gov |
| CS Medical LLC | Creedmoor, NC, United States | Manufacturer, Specification developer | 1 | April 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Specification developer | 1 | May 7, 2002 | 0 | 0 | 0 | api.fda.gov |
| Dort-A Tip Malz San Ith Ihr Tic Ltd Sti | Ankara, Turkey | Manufacturer | 1 | June 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Indilab, Inc. | Franklin Park, IL, United States | Contract manufacturer, Manufacturer | 1 | March 31, 1988 | 0 | 0 | 0 | api.fda.gov |
| Jiangmen New Era External Drug Use Co., Ltd. | Jiangmen Guangdong, China | Exporter to the US, Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Lantor (uk), Ltd. | BOLTON North Yorkshire, United Kingdom | Manufacturer | 1 | October 6, 1988 | 0 | 0 | 0 | api.fda.gov |
| Nanosonics Limited | Macquarie Park New South Wales, Australia | Complaint file establishment, Specification developer | 1 | March 3, 2011 | 0 | 0 | 0 | api.fda.gov |
| Terragene SA | Alvear Santa Fe, Argentina | Manufacturer | 1 | June 30, 2020 | 0 | 1 | 0 | api.fda.gov |
| Tuttnauer Ltd. | BEIT SHEMESH Jerusalem, Israel | Specification developer | 1 | June 30, 2020 | 0 | 0 | 0 | api.fda.gov |
| Weihai Xingtai Packaging Products Co., Ltd. | WeiHai Shandong, China | Exporter to the US, Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| 3M Canada Company | Brockville Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amcor Flexibles, LLC | Mundelein, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Battech | Irvine, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benq Materials Corp. Yunlin Factory 3 | Douliu City Yunlin, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coast Pneumatics, Inc. | Anaheim, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Safesecure Medical Packaging Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fomed Industries Inc | Qian Jiang Hubei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Maidi Medical Co.,ltd | Qingyuan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products Inc. | Buena Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hogy Medical Co., Ltd. | INASHIKI-GUN Ibaraki, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Guarddent Medical Technology Co.,ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IBT Scientific | Creedmoor, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icp, Inc. | Green Bay, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Jsongmed Medical Material Co.,ltd | jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kem Medical Products Corp. | Hauppauge, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicom Asia-Pacific Holdings Limited. Taiwan Branch | Wujie Township Yilan, Taiwan | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicom Healthcare (Thailand) Co., Ltd. | Tambol Nong Yai Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasmapp Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safesecure Medical Packaging Company Limited | Hai Phong City, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jianzhong Medical Packaging Co., Ltd. | Shanghai, China | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sigma Medical Supplies Corp. | Gueishan Taoyuan, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMP Medtech Sdn. Bhd. | Nilai Negeri Sembilan, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPS Medical | COULOMMIERS Seine-et-Marne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterileright Packaging MFG Inc. | Keelung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterivic Medical Co.,ltd. | ChiZhou Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd | Shenzhen City Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianchang Jiarui Packaging Material Co., Ltd. | Tianchang Anhui, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weiman Products, LLC | Gurnee, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.