Skip to the page

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

CountryMakers
China47
United States36
Canada6
United Kingdom4
Germany3
Mexico3
India3
Switzerland2
Australia2
Brazil1
Taiwan1
Sweden1
Poland1
South Korea1
Japan1
Italy1
Russia1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Advanced Sterilization ProductsIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Albert Browne Ltd.Leicester, United KingdomManufacturer0000api.fda.gov
Alconox, LLCWhite Plains, NY, United StatesSpecification developer0000api.fda.gov
Armstrong Manufacturing IncorporatedMississauga Ontario, CanadaContract manufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aimi Health Technology (Guangdong) Co., Ltd.Dongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Align Technology, Inc.San Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.Cd. Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
Anhui GREENLAND BIOTECH CO.,LTDBengbu Anhui, ChinaManufacturer0000api.fda.gov
Baumer S.A.MOGI MIRIM - SP Sao Paulo, BrazilManufacturer0000api.fda.gov
Belimed AGZug, SwitzerlandComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Brain Health Spectrum (chengdu) Artificial Intelligence Technology Co., Ltd.Chengdu Sichuan, ChinaExporter to the US, Manufacturer, Specification developer0000api.fda.gov
BrandmaxJasper, GA, United StatesSpecification developer0000api.fda.gov
Central Solutions, Inc.Kansas City, KS, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Cetylite Industries, Inc.Pennsauken, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Champion Sports Co.,limitedTSIM SHA TSUI Hong Kong, ChinaManufacturer0000api.fda.gov
Changzhou Endoclean Medical Device Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Changzhou Freshday Household Products Corp. Ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Chemclean CorporationJamaica, NY, United StatesManufacturer0000api.fda.gov
Chemische Fabrik DR. Weigert GMBH & Co. KGHamburg, GermanyManufacturer0000api.fda.gov
Chemlink Laboratories, LLC.Kennesaw, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Coltene/Whaledent Inc.Cuyahoga Falls, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Crest Ultrasonics Corp.Ewing, NJ, United StatesManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dent4you AGHeerbrugg Sankt Gallen, SwitzerlandSpecification developer0000api.fda.gov
Dentsply LLCMilford, DE, United StatesContract manufacturer0000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer0000api.fda.gov
Digimax Innovative Products LtdNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Dikaku Industrial Co.,limitedHong Kong, ChinaManufacturer0000api.fda.gov
Diversified Chemical Products, IncWilmington, DE, United StatesContract manufacturer0000api.fda.gov
Dongguan Qianhe Electronic Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Contract sterilizer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan Yipincheng Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Ekong Technology Co., Limited.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
Foshan Gezhe Technology Co., Ltdfoshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Foshan Nanhai Plus Medical Co LtdFoshan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Germiphene Corp.BRANTFORD Ontario, CanadaManufacturer0000api.fda.gov
Getinge Disinfection ABVAXJO Kronoberg, SwedenManufacturer0000api.fda.gov
Guangdong Eraclean Technology Co.,ltdZhongshan City Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong GT Ultrasonic Co.,ltdMeizhou Guangdong, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Guangdong Souncrise Technology Co.,ltdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Guangxi Ehall Medical Technology Co.,ltdNanning Guangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Guangzhou Ajax Medical Equipment Co LtdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Getinge IC Production Poland sp. z o.o.Plewiska Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Hdi Inc.Seongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Huizhou Gold Rose Technology Co.,ltdhuizhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Intercon Chemical Co.St. Louis, MO, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Isonic Inc.Chicago, IL, United StatesRemanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltdTianjin, ChinaManufacturer0000api.fda.gov
KP Dental LLCWilmington, DE, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesSpecification developer0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesContract manufacturer0000api.fda.gov
L&R MFG. Co., IncKearny, NJ, United StatesManufacturer0000api.fda.gov
L&R MFG. Co., Inc.Kearny, NJ, United StatesManufacturer0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Mark EnterprisesNashik Maharashtra, IndiaManufacturer0000api.fda.gov
Marken Healthtech LimitedNASHIK Maharashtra, IndiaManufacturer0000api.fda.gov
Maxill, Inc.ST. THOMAS Ontario, CanadaManufacturer0000api.fda.gov
Medisafe Uk Ltd.Bishops Stortford Hertfordshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
MicroCare MedicalCommerce City, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Micrylium Laboratories Inc.TORONTO Ontario, CanadaManufacturer0000api.fda.gov
Ningbo Jianjie Daily And Cosmetics Co., Ltd.Cixi Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Just Soon Industrial LimitedNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Novapharm Research Australia Pty LtdRosebery New South Wales, AustraliaManufacturer0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
P & T MedicalNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Pascal International, Inc.Bellevue, WA, United StatesManufacturer0000api.fda.gov
Quadralene LtdDerby, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Royal Chemical CompanyMacedonia, OH, United StatesContract manufacturer0000api.fda.gov
Scican Ltd.TORONTO Ontario, CanadaManufacturer0000api.fda.gov
Shanghai Link Instruments Co.,ltdChangzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Shenzhen Codyson Electrical Co, LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Fanr Technology Co.,ltdshenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hongsheng Network Technologyco.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Jie Bishi Technology Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Joose Beauty Electronic Co.,ltdShen Zhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Shenzhen Lunata Technology Co., LtdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Mebao Intelligent Technology Co.,ltdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mlikang Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Samo Technology Co.,limitedShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Zhiqi Technology Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Sonic Systems, Inc.Ivyland, PA, United StatesManufacturer0000api.fda.gov
Southmedic, Inc.BARRIE Ontario, CanadaComplaint file establishment, Foreign private label distributor, Specification developer0000api.fda.gov
Steelco S.P.A.Riese Pio X Treviso, ItalyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Steris CorporationBreckenridge Hills, MO, United StatesManufacturer for export, Repackager or relabeler0000api.fda.gov
Steris CorporationSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Manufacturer for export0000api.fda.gov
Shenzhen Heearly Technology Co.,Ltd.Bao an District, Shenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenzhen Jie Zhong Lian Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Symmetry Surgical GmbHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
TBJ IncorporatedChambersburg, PA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
The Ruhof CorporationMineola, NY, United StatesManufacturer0000api.fda.gov
Touchstone International Medical Science Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Tribest Dental Products Co LtdYangzhong Jiangsu, ChinaManufacturer0000api.fda.gov
Ultrawave LimitedCardiff, United KingdomManufacturer0000api.fda.gov
United BiotechDeer Park, NY, United StatesSpecification developer0000api.fda.gov
Vintage Chemical Inc.Fort Wayne, IN, United StatesManufacturer0000api.fda.gov
Whiteley Corporation Pty LtdTomago New South Wales, AustraliaManufacturer0000api.fda.gov
Xiamen Atyou Health Technology Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yelatma Instrument-Making EnterpriseRyazan Ryazanskaya Oblast', RussiaManufacturer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesSpecification developer0010api.fda.gov
Yangzhou Fartley Medical Instrument Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Fomos Medical Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Pusu Electric Appliance Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.Zhengzhou Henan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhongshan BestClean Technology Co.,Ltdzhongshan Guangdong, ChinaExporter to the US, Manufacturer0000api.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.