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Data / Medical devices / Support, Hernia

Support, Hernia (EXN): 62 FDA-registered makers in 22 countries

62 establishments in 22 countries are registered with the FDA to make Support, Hernia (product code EXN, Class 1, 21 CFR 876.5970). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 26, 1990, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EXN
Device class
1
Regulation
876.5970
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
China14
United States9
Taiwan7
India6
United Kingdom3
Turkey3
Germany2
Vietnam2
Italy2
Latvia2
Canada1
Netherlands1
Chile1
Mexico1
Cambodia1
Colombia1
Pakistan1
Egypt1
Spain1
Denmark1
Slovakia1
Japan1

Makers of Support, Hernia

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
Airway Surgical Appliances Ltd.NEPEAN Ontario, CanadaManufacturer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, NetherlandsComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Brace AlignSoddy Daisy, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bort GmbHWEINSTADT-BENZACH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
CUI International LimitedBurbage Hinckley Leicestershire, United KingdomManufacturer0000api.fda.gov
Core Products International IncChetek, WI, United StatesManufacturer0000api.fda.gov
Docbrace (cambodia) Co., LtdPhnom Penh Capital, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Redthera Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesSpecification developer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Indaco S.R.L.Filiano Potenza, ItalyExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Xiangyu Fitness Equipment Co., Ltd.Yangzhong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Kamex International S.A.SCajica Cundinamarca, ColombiaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim SirketiSalihli Manisa, TurkeyManufacturer0000api.fda.gov
Le Shin International Co., Ltd.Kaohsiung,, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Lsez Sia Lauma Medical / Lauma Medical Lsez LLCLiepaja, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Mammon International Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Melpex Beauty InstrumentsSialkot Punjab, PakistanManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Neo G LimitedKnaresborough North Yorkshire, United KingdomManufacturer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer0000api.fda.gov
Pavis S.P.A.Buguggiate Varese, ItalyManufacturer0000api.fda.gov
Power Well Healthcare Technology Co., Ltd.Changhua County, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Promedics Orthopaedic LtdPort Glasgow Scotland, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Safe N Simple LLCClarkston, MI, United StatesManufacturer0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Sia Tonus Elast / Tonus Elast LLC.Grinvalti,Nicas pag Nicas Novads, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Special Protectors Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Surgical Appliance Industries, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Suzhou Kangyouwei Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Tuper Medical Co., Ltd.Dezhou City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Tytex Denmark A/SIKAST Midtjylland, DenmarkContract manufacturer0000api.fda.gov
Tytex Slovakia S.R.O.HUMENNE Presovsky, SlovakiaManufacturer0000api.fda.gov
U.S. Orthotics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd StiKUCUKCEKMECE Istanbul, TurkeyContract manufacturer, Manufacturer0000api.fda.gov
Variteks Ortopedi Sanayi A.S.Catalca Istanbul, TurkeyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Women's Medical Research Inc.Toshima-ku Tokyo, JapanManufacturer0000api.fda.gov
Xiamen Chengli Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Huakang Orthopedic Co.,ltdXiamen City Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Longstar Medical Equipment Co.,ltdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated October 26, 1990. 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.