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Data / Medical devices / Bandage, Cast

Bandage, Cast (ITG): 164 FDA-registered makers in 27 countries

164 establishments in 27 countries are registered with the FDA to make Bandage, Cast (product code ITG, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 37 510(k) clearances under this code, the latest on October 9, 1987, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ITG
Device class
1
Regulation
890.3025
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China57
United States42
South Korea10
Mexico10
India6
Germany6
Taiwan4
Vietnam3
United Kingdom2
Israel2
Pakistan2
Egypt2
Thailand2
Japan2
Belgium2
Colombia1
Canada1
Dominican Republic1
Italy1
Guatemala1
Honduras1
Malaysia1
Czechia1
Brazil1
Austria1
France1
Poland1

Makers of Bandage, Cast

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
Acell, Inc.Columbia, MD, United StatesSpecification developer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Andover Healthcare, Inc.Salisbury, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Anhui Ivymed Medical Products Co. LtdXuancheng Anhui, ChinaContract manufacturer0000api.fda.gov
Anji Hengfeng Sanitary Material Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Huifeng Surgical Dressings Co., Ltd.ANJI COUNTY Zhejiang, ChinaComplaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
Anji Sanfang Medical Device Co., Ltd.anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Anhui Dajiang Medical Products Co.,Ltd.chuzhou Anhui, ChinaManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
BL Tech Co., Ltd.Chuncheon-si Gangwon, South KoreaManufacturer0000api.fda.gov
Blue Blood Biotech Corp.Taipei City, TaiwanManufacturer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
BSN medical Limitada (COLOMBIA)CALI Valle del Cauca, ColombiaManufacturer0000api.fda.gov
Carolina Narrow Fabric Co.Winston-Salem, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
Culzean Textile Solutions LtdIrvine North Ayrshire, United KingdomContract manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal HealthAugusta, GA, United StatesManufacturer0000api.fda.gov
Datt Mediproducts Private LimitedSOHNA Haryana, IndiaManufacturer0000api.fda.gov
Degasa, S.A. De C.V.Jiutepec Morelos, MexicoManufacturer, Specification developer0000api.fda.gov
Derma Sciences Canada, IncTORONTO Ontario, CanadaContract manufacturer0000api.fda.gov
Derma Sciences Nantong IncorporationDEVELOPMENT Jiangsu, ChinaContract manufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan Shin Yi Healthcare Products FactoryDONG GUAN CITY Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
DR. Sabharwal's Wound CareBAROTIWALA Himachal Pradesh, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaManufacturer0000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesSpecification developer0000api.fda.gov
Eurofarm SPABelpasso Catania, ItalyManufacturer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer0000api.fda.gov
Fesun Shanghai Co., Ltd.shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Freudenberg Performance Materials GmbH & Co. KGWeinheim Baden-Wurttemberg, GermanyContract manufacturer, Exporter to the US0000api.fda.gov
Galia Textil S.A. De C.V.Xiloxoxtla, Tlaxcala, MexicoContract sterilizer, Manufacturer0000api.fda.gov
Gauke (hubei) Healthcare Co., LtdHuanggang City Hubei, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
GFA Production Xiamen Co., Ltd.Tong An, Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hangzhou Rollmed Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. LtdHangzhou City Zhejiang, ChinaManufacturer0000api.fda.gov
Haody Medical Technology (vietnam) Company LimitedHo Chi Minh City, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Hartmann Usa Inc.Rock Hill, SC, United StatesSpecification developer0000api.fda.gov
Hilbro (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Hospora IncIrvine, CA, United StatesSpecification developer0000api.fda.gov
Huae Trade Technology Co.,ltd.Beijing, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer0000api.fda.gov
Hubei V-Medical Products Co., Ltd.Xiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou GspMed Medical Appliances Co., Ltd.Hangzhou City Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hebei Ruinuo Medical Instrument Co LtdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Integra Pain ManagementWest Valley City, UT, United StatesContract manufacturer0000api.fda.gov
Jianerkang Medical Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Jiangsu Likang Medical Products Co., Ltd.WUJIANG CITY Jiangsu, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Jiangsu Senolo Medical Technology Co., Ltd.Yancheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiujiang Huada Medical Dressing Co., Ltd.JIUJIANG Jiangxi, ChinaManufacturer0000api.fda.gov
JM Medical Co., Ltd.Liaocheng Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jmar Medical LLCNashville, TN, United StatesSpecification developer0000api.fda.gov
Join Enterprise, Ltd.Yongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
KOB GmbHWolfstein Rhineland-Palatinate, GermanyContract manufacturer0010api.fda.gov
Kingstar Medical (Xianning) Co., Ltd.Xianning City Hubei, ChinaContract manufacturer0000api.fda.gov
L Well Medtech Solutions Sdn. Bhd.Nibong Tebal Pulau Pinang, MalaysiaManufacturer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Lantor (uk), Ltd.BOLTON North Yorkshire, United KingdomContract manufacturer0000api.fda.gov
Lohmann & Rauscher GMBH & Co. KGNEUWIED Rhineland-Palatinate, GermanyManufacturer, Specification developer0000api.fda.gov
Lohmann & Rauscher s.r.o.Stara Paka Jicin, CzechiaContract manufacturer0000api.fda.gov
Marketlab IncorporatedCaledonia, MI, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medstar Healthcare Co.,limitedHuzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Nanjing Asn Medical Technology Co.,ltdNANJING Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
New Cast Industry Co. Ltd.Ulsan, South KoreaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Suncity Package Co.,ltdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Onsurgical Corp.Seoul, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Openm Inc.Yuseong-gu Daejeon, South KoreaManufacturer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Ortho Pauher Ind. Com. E Dist. LtdaRecife Pernambuco, BrazilExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Otto Bock Healthcare Products GmbHVienna Wien, AustriaManufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyExporter to the US, Specification developer0000api.fda.gov
Paceline, Inc.Matthews, NC, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Performance Health Supply, LLC.Cedarburg, WI, United StatesSpecification developer0000api.fda.gov
Pharmaplast S.A.E.ALEXANDRIA Al Iskandariyah, EgyptContract manufacturer, Manufacturer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Prime Medical, Inc.HWASEONG-SI Gyeonggi, South KoreaContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
ProteorDijon Cedex Cote-d'Or, FranceManufacturer0000api.fda.gov
Proteor UsaTempe, AZ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
PROTEOR USA, GunnisonGunnison, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Puli Healthcare (thailand) Co., Ltd.Bangkok Samut Prakan, ThailandExporter to the US, Manufacturer0000api.fda.gov
Phiten Co., Ltd.Kyoto, JapanManufacturer0000api.fda.gov
Prime Medica Promotion Private LimitedVadodara Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.Pinghu City Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Runlite S.A.SOUMAGNE Liege, BelgiumManufacturer0000api.fda.gov
S & F IncBuk-gu Busan, South KoreaManufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.Xi'an Shaanxi, ChinaManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Siam Cotton Wool Ltd.Phrapradaeng Samut Prakan, ThailandContract manufacturer0000api.fda.gov
Sion Biotext Medical LtdSderot Southern, IsraelContract manufacturer, Manufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
SplintboxFrontenac, MO, United StatesManufacturer, Specification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
SurgicraftsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Suzhou Avon Textile Co., Ltd.Suzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Emy Medical Supplies Co.,ltd.ChangShu Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Suzhou Haody Medical Products Co. Ltd.Suzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Suzhou Pulikang Medical Device Co LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Suzhou Vicon Industrial Co., LtdSUZHOU Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Sion Biotext Mexico, S.A.P.I. De C.V.Civac Mexico, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Sion Biotext Mexico, S.A.P.I. de C.VJiutepec Morelos, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Solventum Germany GmbHKamen North Rhine-Westphalia, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Solventum Poland Manufacturing SP. ZO.OWroclaw Dolnoslaskie, PolandManufacturer, Specification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sterling Medical ProductsProphetstown, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Suzhou Dukangning Medical Products Co., LtdSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
T&L (jiaxing) Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Tex-Care MedicalBurlington, NC, United StatesSpecification developer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Toyo Resin CorporationFUJI Shizuoka, JapanManufacturer0000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Twe Dierdorf GMBH And Co. KGDierdorf Rhineland-Palatinate, GermanyContract manufacturer0000api.fda.gov
TWE Meulebeke NVMeulebeke West-Vlaanderen, BelgiumContract manufacturer0000api.fda.gov
TWE Nonwovens US, Inc.High Point, NC, United StatesContract manufacturer0000api.fda.gov
Tomato M&C Co.,LtdPyeongtaek-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Viet - Long An Medical Supply Company Ltd.Long An, VietnamContract manufacturer, Manufacturer0000api.fda.gov
WCC BIOMEDICAL Co., LtdHsinchu City Hsinchu(City), TaiwanManufacturer0000api.fda.gov
Wear Tex S. De R.L. De C.V.Torreon Coahuila, MexicoContract manufacturer, Exporter to the US0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
WeslacovaNorth Wilkesboro, NC, United StatesContract manufacturer0000api.fda.gov
Woosam Medical Co., Ltd.Paju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
WPT CorporationBeaver Dam, KY, United StatesManufacturer0000api.fda.gov
Wuhan Sitaili Medical Apparatus Development Co.,ltdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Welmed, Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Wenzhou Scico Medical Corporation Co.,Ltd.Longgang, Wenzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Wenzhou Shengkai Technology Industry Co.,LtdWenzhou city Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiantao Rayxin Medical Products Co., Ltd.XIANTAO Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xo Armor Technologies IncAuburn, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Xuchang Zhende Surgical Dressing Co.,ltd.Xuchang Henan, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yiwu Jiekang Medical Articles Co., Ltd.Yiwu, Zhejiang, ChinaManufacturer0000api.fda.gov
Yoorim Corp.EUMSEONG-GUN Chungbuk, South KoreaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Kekang Medical Technology Co., LtdYueqing City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov

Updated October 9, 1987. 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.