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Data / Medical devices / Gown, Examination

Gown, Examination (FME): 189 FDA-registered makers in 20 countries

189 establishments in 20 countries are registered with the FDA to make Gown, Examination (product code FME, Class 1, 21 CFR 880.6265). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on February 19, 1988, and lists 1 recall event (0 Class I). FDA data exported November 3, 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
FME
Device class
1
Regulation
880.6265
Medical specialty
General Hospital

Makers by country

CountryMakers
China86
United States35
Pakistan13
Vietnam12
India9
Mexico6
Cambodia5
Bangladesh4
South Korea3
Canada3
Myanmar2
Thailand2
El Salvador2
Taiwan1
Hong Kong1
Sri Lanka1
Laos1
Peru1
Kenya1
Haiti1

Makers of Gown, Examination

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
Adroit Medical Systems, Inc.Loudon, TN, United StatesManufacturer0000api.fda.gov
Aimmax Medical Products Co.,ltd.Shiyan Hubei, ChinaContract manufacturer0000api.fda.gov
Allcare, Inc.St Charles, IL, United StatesSpecification developer0000api.fda.gov
Alphaprotech, Inc.Nogales, AZ, United StatesSpecification developer0000api.fda.gov
Am NonwovensMadurai Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Amaryllis Healthcare Pvt. LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
American Dawn Inc.Compton, CA, United StatesSpecification developer0000api.fda.gov
Ammar Apparel Ii S. De R.L De C.V.CALKINI Campeche, MexicoManufacturer, Specification developer0000api.fda.gov
Andersen Industries Co., Ltd.Angsnoul District Kandal, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Angeline Group Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Anhui JM Healthcare Products Co.,ltd.Shouxian Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anyang Sukangning Medical Products Co., LtdAnyang Henan, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Arrow Medsource Group LimitedHongkong, ChinaExporter to the US, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesSpecification developer0000api.fda.gov
AZTA Textile Solutions (Pvt) LtdKarachi East Sindh, PakistanExporter to the US, Manufacturer0000api.fda.gov
Arshad Corporation (Pvt) LtdFaisalabad Punjab, PakistanExporter to the US, Manufacturer0000api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Beximco Ppe LimitedDhaka Dhaka(Division), BangladeshExporter to the US, Manufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Binzhou Dingyue Clothing Company LimitedBinzhou Shandong, ChinaContract manufacturer0000api.fda.gov
Blue Sail (hong Kong) Trading LimitedHarbour, Hong KongExporter to the US, Specification developer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesSpecification developer0000api.fda.gov
C K Hygiene Pvt LtdHyderabad Telangana, IndiaContract manufacturer0000api.fda.gov
Casco Manufacturing Solutions, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Changzhou Care-De Sanitary Material Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Holymed Products Co., LtdCHANGZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Changzhou Hongtai Paper Film Co., LtdChangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
Cobes Industries (bago) Company LimitedBago, MyanmarContract manufacturer, Contract sterilizer0000api.fda.gov
Cobes Industries (bii) Company LimitedBago Region, MyanmarContract manufacturer0000api.fda.gov
Copious (cambodia) International Inc.Takeo, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Copious Intl., Inc.Heyuan, Guangdong Province, ChinaContract manufacturer0000api.fda.gov
Core Products International IncChetek, WI, United StatesManufacturer0000api.fda.gov
Crown Name Disposable Hygiene Products Fty. Ltd.Wuhan Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Daemyung Chemical Co., Ltd (vietnam)An Phuoc Commune Dong Nai, VietnamManufacturer0000api.fda.gov
Dasol International Ltd.Siheung-Si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Dongguan Shin Yi Healthcare Products FactoryDONG GUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ecollink Non-Woven Company LimitedHongkong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Emerald Nonwovens Intl. Co., Ltd.Phetchaburi, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
Fabrication Ent., Inc.Elmsford, NY, United StatesManufacturer0000api.fda.gov
Fengyang Jiehong Nonwoven Product Co., Ltd.Chuzhou City Anhui, ChinaContract manufacturer0000api.fda.gov
Foshan Hongfeng Co.,ltdFoshan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Fullstar Non-Woven Products Co.,ltd.Xiantao City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Feroze1888 MillsKARACHI Sindh, PakistanContract manufacturer0000api.fda.gov
Fujian Dashan Paper CO LTDQUANZHOU Fujian, ChinaContract manufacturer0000api.fda.gov
GD Group USA CompanyBartlett, IL, United StatesSpecification developer0000api.fda.gov
George Courey IncMontreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Guangzhou Fuzelong Hygiene Material Co.,ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Harley Commodity Company LimitedGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Goodwood Medical Care LtdDalian Liaoning, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaSpecification developer0000api.fda.gov
Gushi priMED Medical Products Manufacturing Co., Ltd.Gushi County Henan, ChinaContract manufacturer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Hanh Minh Manufacturing Trading Company LimitedBien Hoa Dong Nai, VietnamManufacturer, Repackager or relabeler0000api.fda.gov
Haody Medical Technology (vietnam) Company LimitedHo Chi Minh City, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Harmony Plastics Private LtdSurat Gujarat, IndiaManufacturer0000api.fda.gov
Hartford HealthcareHartford, CT, United StatesSpecification developer0000api.fda.gov
Hefei Jingcheng Plastic Products Co. LtdHefei Anhui, ChinaManufacturer0000api.fda.gov
Hindustan Apparel IndustriesHyderabad Telangana, IndiaManufacturer0000api.fda.gov
HK Surgical, Inc.San Clemente, CA, United StatesSpecification developer0000api.fda.gov
Honghu Danielle Sanitary Material Co., Ltd.Honghu City Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HPK IndustriesFrankfort, NY, United StatesManufacturer0000api.fda.gov
Hubei Deming Healthcare Products Co.,ltd.Xiantao Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hubei Deming Healthcare Products Co.,ltd.first BranchXiantao City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hubei Feiteng Protective Products Co.,ltdXiantao Hubei, ChinaManufacturer0000api.fda.gov
Hubei Fumo Paper Products Co. LtdWuhan Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hubei Huanfu Plastic Products Co., LtdHANCHUAN CITY Hubei, ChinaManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer0000api.fda.gov
Hubei Weikang Protective Products Co.ltdXIANTAO Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Halyard North Carolina, LLCLinwood, NC, United StatesManufacturer0000api.fda.gov
Harmony Plastics P. Ltd.Udaipur Rajasthan, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Heaven Healthcare Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.fda.gov
Hebei Ruinuo Medical Instrument Co LtdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Hefei Xingcheng Sanitary Products CO.,LTDHefei Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Hubei Haixin Protective Products Group Co.,LtdSongzi City Hubei, ChinaManufacturer0000api.fda.gov
Hubei Yiye Plastics Co. LTDTianmen Hubei, ChinaManufacturer0000api.fda.gov
Icat S.A. De C.V.San Salvador, El SalvadorContract manufacturer0000api.fda.gov
Intco Medical Technology Viet Nam Company LimitedDong Mai Ward Quang Ninh, VietnamManufacturer0000api.fda.gov
International Textile LimitedKarachi Sindh, PakistanContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoManufacturer0000api.fda.gov
Jiangsu Hanfang Textile Technology Co., LtdXuzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Medplus Non-Woven Manufacturer Co.,ltd.Siyang Jiangsu, ChinaManufacturer0000api.fda.gov
Jiehong Medical Products(bangladesh) Co.ltdChattogram Chittagong(Division), BangladeshContract manufacturer0000api.fda.gov
Jiehong Nonwoven Products(bd) Co.,ltdChattogram Chittagong(District), BangladeshContract manufacturer, Manufacturer0000api.fda.gov
Jingzhou Haixin Green Cross Medical Products Co.,ltdJingzhou Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Guangda Medical Material Group Co., Ltd.Haian Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangyin Huaying Light Industrial Products Co., LTDJiangyin Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Liberty Mills, Ltd.KARACHI Sindh, PakistanManufacturer, Specification developer0000api.fda.gov
Lingxian Dongsheng Textile Co., Ltd.Dezhou Shandong, ChinaManufacturer0000api.fda.gov
Lucky ImpexKarachi Sindh, PakistanContract manufacturer, Exporter to the US0000api.fda.gov
Lucky Textile Mills LimitedKARACHI Sindh, PakistanContract manufacturer, Exporter to the US0000api.fda.gov
La Ada de AcunaCIUDAD DE ACUNA Coahuila, MexicoManufacturer0000api.fda.gov
Lianyungang Anson Non-woven Product Co., Ltd.Lianyungang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Lianyungang Bronson Non-woven Products Co., Ltd.LIANYUNGANG Jiangsu, ChinaContract manufacturer0000api.fda.gov
Little Rapids CorporationGreen Bay, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Manufacturas KeNogales Sonora, MexicoContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoManufacturer0000api.fda.gov
Master & Frank (cambodia) Co., Ltd.Angsnoul Kandal, CambodiaContract manufacturer0000api.fda.gov
MB Regentox Vietnam Trading Service Company LimitedHo Chi Minh City, VietnamForeign private label distributor, Manufacturer0000api.fda.gov
MDK (shanghai) Medical Packing Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtecs (cambodia) Corp. LimitedSrok Kampong Siem Kampong Cham, CambodiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Minra Garments (pvt) LtdPuttlam North Western, Sri LankaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Mip UsaBolingbrook, IL, United StatesSpecification developer0000api.fda.gov
Mip, Inc.ANJOU Quebec, CanadaSpecification developer0000api.fda.gov
Mustaqim Dyeing & Printing Industries (pvt.) Ltd.Karachi Sindh, PakistanContract manufacturer0000api.fda.gov
Medegen Medical ProductsGallaway, TN, United StatesSpecification developer0000api.fda.gov
Ningjin Runboda Medical Protective Products Co., Ltd.Xingtai Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Nurses Choice Corp.Wilmington, NC, United StatesManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Operating Theatre Medical Bangladesh Company LimitedKaliakair Gazipur, BangladeshContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Patientstyle Medical LLCSan Leandro, CA, United StatesManufacturer0000api.fda.gov
Prestige AmeritechNorth Richland Hills, TX, United StatesManufacturer0000api.fda.gov
PRIMED Laos Medical Products Manufacturing Sole Co., Ltd.Vientiane Capital Viangchan(Prefecture), LaosContract manufacturer0000api.fda.gov
Primed Medical Products Inc.Edmonton Alberta, CanadaSpecification developer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.Pinghu City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock CorporationDien Ban Bac Ward Da Nang, VietnamContract manufacturer, Manufacturer0000api.fda.gov
R & G Seguridad E Higiene Industrial S.A.C.VENTANILLA Lima(Province), PeruManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Reolite Company Inc.Seoul, South KoreaManufacturer0000api.fda.gov
Rugao Smiling Healthcare Teconolgy Developent Co., LtdRugao Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Samaritan Textile (cambodia) Co., Ltd.Phnom Penh, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Sanmu (vietnam) Protective Products Co., LtdDuc Hoa Commune Tay Ninh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Sejong Healthcare Co., Ltd.Paju Gyeonggi, South KoreaManufacturer0000api.fda.gov
Shah SafariSeattle, WA, United StatesContract manufacturer0000api.fda.gov
Shandong Hengfa Hygienic Products Co.,ltd.Linqing City,liaocheng City, Shandong, ChinaManufacturer0000api.fda.gov
Shunde Lucas IndustriesFoshan City Guangdong, ChinaManufacturer0000api.fda.gov
Silver Plus Corp.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Standard Textile Co., Inc.Cincinnati, OH, United StatesSpecification developer0000api.fda.gov
Star FabricsFaisalabad Punjab, PakistanManufacturer0000api.fda.gov
Stavian Chemical Joint Stock CompanyNhu Quynh Commune Hung Yen, VietnamContract manufacturer0000api.fda.gov
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Superior Group Of Companies, Inc.Saint Petersburg, FL, United StatesSpecification developer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Simba Apparel EPZ LTDMombasa, KenyaContract manufacturer0000api.fda.gov
Sino Protection (Hefei) Medical Products Co. ltd.HEFEI Anhui, ChinaContract manufacturer0000api.fda.gov
Small Beginnings Inc.Hesperia, CA, United StatesManufacturer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Sultex Industrieskarachi Sindh, PakistanManufacturer0000api.fda.gov
Superior SourcingQuanaminthe Nord-Est, HaitiContract manufacturer, Manufacturer0000api.fda.gov
Suzhou Dukangning Medical Products Co., LtdSuzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Thai Hospital Products Co., Ltd.Muang Samut Prakan, ThailandContract manufacturer, Manufacturer0000api.fda.gov
Theni Guru Krishna Textile Mills (P) Ltd.Theni Tamil Nadu, IndiaContract manufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Topwin(hubei) Medical Products ManufacturerSuizhou Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Transparent Supply Solutions Ltd.Dover, DE, United StatesSpecification developer0000api.fda.gov
U.S. Pacific Nonwovens Technology (Dongguan) LtdDongguan City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
United towel ExportersKarachi Sindh, PakistanManufacturer0000api.fda.gov
V&Q Manufacturing CorporationXiantao Hubei, ChinaManufacturer0000api.fda.gov
Vien Phat Import Export Service Trading Joint Stock CompanyBen Thanh Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
VT Production Medical Materials Production CorporationCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Vidales Larranaga SA de CVAhuachapan, El SalvadorContract manufacturer0000api.fda.gov
Wear Tex S. De R.L. De C.V.Torreon Coahuila, MexicoContract manufacturer, Exporter to the US0000api.fda.gov
Weihai Dishang Medical Technology Co.,ltdWeihai Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Wuhan Huaxin Nonwoven Co., LtdWuhan Hubei, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Wuhan Lucky Star Non Woven Products Co LtdWuhan Hubei, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Wuhan Zonsen Medical Products Co., LtdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Wellmed Dental Medical Supply Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Xian Tao Crosscare Protective Products Co.,ltdXian Tao Hubei, ChinaManufacturer0000api.fda.gov
Xiantao City Songqing Plastic Products Co., Ltd.Xiantao Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiantao Hooray Protective Products Co.,ltdXiantao City Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiantao Junhui Plastic Products Co.,ltd.Xiantao Hubei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Xiantao Rayxin Medical Products Co., Ltd.XIANTAO Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
XIANTAO XINFA PLASTIC PRODUCTS Co. LTD.Xiantao City Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xiantao Xingrong Protective Products Co., Ltd.Xiantao Hubei, ChinaManufacturer0000api.fda.gov
Xiantao Zhongyi Safety & Protection Products Co.,Ltd.Xiantao City Hubei, ChinaManufacturer0000api.fda.gov
Yadu Medical (henan) Co., LtdChangyuan Henan, ChinaManufacturer0000api.fda.gov
Yancheng Jingwei Chemicals Co., LtdYancheng Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Weideli Trading Co., Ltd.Yangzhou Jiangsu, ChinaSpecification developer0000api.fda.gov
Yunus Textile Mills LimitedKarachi Sindh, PakistanManufacturer0000api.fda.gov
Zaozhuang Huayang Hongdan Clothing Co., Ltd.Zhaozhang Jiangsu, ChinaContract manufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zibo Dayang Flame Retardant Textile Co.,ltdZibo Shandong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zibo Intco Medical Products Company LimitedZibo Shandong, ChinaContract manufacturer0000api.fda.gov
priMED Jiujiang Medical Products Manufacturing Co., LtdJiujiang Jiangxi, ChinaContract manufacturer0000api.fda.gov

Updated February 19, 1988. 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.