Data / Medical devices / Cleaner, Ultrasonic, Medical Instrument
Cleaner, Ultrasonic, Medical Instrument (FLG): 114 FDA-registered makers in 17 countries
114 establishments in 17 countries are registered with the FDA to make Cleaner, Ultrasonic, Medical Instrument (product code FLG, Class 1, 21 CFR 880.6150). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on December 20, 1994, and lists 6 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
- FLG
- Device class
- 1
- Regulation
- 880.6150
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 47 |
| United States | 36 |
| Canada | 6 |
| United Kingdom | 4 |
| Germany | 3 |
| Mexico | 3 |
| India | 3 |
| Switzerland | 2 |
| Australia | 2 |
| Brazil | 1 |
| Taiwan | 1 |
| Sweden | 1 |
| Poland | 1 |
| South Korea | 1 |
| Japan | 1 |
| Italy | 1 |
| Russia | 1 |
Makers of Cleaner, Ultrasonic, Medical Instrument
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 |
|---|---|---|---|---|---|---|---|---|
| Ackermann Instrumente GMBH | RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Sterilization Products | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Albert Browne Ltd. | Leicester, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alconox, LLC | White Plains, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armstrong Manufacturing Incorporated | Mississauga Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Align Technology, Inc. | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aligntech de Mexico S, de R. L. de C. V. | Cd. Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui GREENLAND BIOTECH CO.,LTD | Bengbu Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baumer S.A. | MOGI MIRIM - SP Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Belimed AG | Zug, Switzerland | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brain Health Spectrum (chengdu) Artificial Intelligence Technology Co., Ltd. | Chengdu Sichuan, China | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brandmax | Jasper, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Central Solutions, Inc. | Kansas City, KS, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cetylite Industries, Inc. | Pennsauken, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Champion Sports Co.,limited | TSIM SHA TSUI Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Freshday Household Products Corp. Ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemclean Corporation | Jamaica, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemische Fabrik DR. Weigert GMBH & Co. KG | Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chemlink Laboratories, LLC. | Kennesaw, GA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crest Ultrasonics Corp. | Ewing, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dent4you AG | Heerbrugg Sankt Gallen, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | Milford, DE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digimax Innovative Products Ltd | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dikaku Industrial Co.,limited | Hong Kong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diversified Chemical Products, Inc | Wilmington, DE, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Qianhe Electronic Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yipincheng Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ekong Technology Co., Limited. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Gezhe Technology Co., Ltd | foshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Nanhai Plus Medical Co Ltd | Foshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Germiphene Corp. | BRANTFORD Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getinge Disinfection AB | VAXJO Kronoberg, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Eraclean Technology Co.,ltd | Zhongshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong GT Ultrasonic Co.,ltd | Meizhou Guangdong, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Souncrise Technology Co.,ltd | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangxi Ehall Medical Technology Co.,ltd | Nanning Guangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Getinge IC Production Poland sp. z o.o. | Plewiska Wielkopolskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hdi Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Gold Rose Technology Co.,ltd | huizhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intercon Chemical Co. | St. Louis, MO, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isonic Inc. | Chicago, IL, United States | Remanufacturer, Repackager or relabeler, 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 | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KP Dental LLC | Wilmington, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&R MFG. Co., Inc | Kearny, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&R MFG. Co., Inc. | Kearny, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxill, Inc. | ST. THOMAS Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medisafe Uk Ltd. | Bishops Stortford Hertfordshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroCare Medical | Commerce City, CO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micrylium Laboratories Inc. | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Jianjie Daily And Cosmetics Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Just Soon Industrial Limited | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novapharm Research Australia Pty Ltd | Rosebery New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onlycare Inc | Denver, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P & T Medical | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Dental Products Co. | Plymouth Meeting, PA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pascal International, Inc. | Bellevue, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quadralene Ltd | Derby, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Royal Chemical Company | Macedonia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scican Ltd. | TORONTO Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Link Instruments Co.,ltd | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Codyson Electrical Co, Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Fanr Technology Co.,ltd | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hongsheng Network Technologyco.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Bishi Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Joose Beauty Electronic Co.,ltd | Shen Zhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lunata Technology Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mebao Intelligent Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mlikang Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Samo Technology Co.,limited | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Zhiqi Technology Co., Ltd. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonic Systems, Inc. | Ivyland, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Complaint file establishment, Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steelco S.P.A. | Riese Pio X Treviso, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steris Corporation | Breckenridge Hills, MO, United States | Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steris Corporation | Saint Louis, MO, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Heearly Technology Co.,Ltd. | Bao an District, Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TBJ Incorporated | Chambersburg, PA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Ruhof Corporation | Mineola, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touchstone International Medical Science Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tribest Dental Products Co Ltd | Yangzhong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultrawave Limited | Cardiff, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Biotech | Deer Park, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vintage Chemical Inc. | Fort Wayne, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whiteley Corporation Pty Ltd | Tomago New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Atyou Health Technology Co., Ltd. | Xiamen Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yelatma Instrument-Making Enterprise | Ryazan Ryazanskaya Oblast', Russia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Fomos Medical Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Pusu Electric Appliance Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan BestClean Technology Co.,Ltd | zhongshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 20, 1994. 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.