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Data / Medical devices / Binder, Abdominal

Binder, Abdominal (FSD): 98 FDA-registered makers in 22 countries

98 establishments in 22 countries are registered with the FDA to make Binder, Abdominal (product code FSD, Class 1, 21 CFR 880.5160). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 20, 1989, and lists 0 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
FSD
Device class
1
Regulation
880.5160
Medical specialty
General Hospital

Makers by country

CountryMakers
United States31
China19
Taiwan10
India7
Mexico5
Dominican Republic3
Vietnam3
Canada2
Tunisia2
Cambodia2
Guatemala2
Italy2
Colombia1
Turkey1
Honduras1
Hong Kong1
Czechia1
Egypt1
Philippines1
Iceland1
United Kingdom1
Bangladesh1

Makers of Binder, Abdominal

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
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
3M Edumex, S.A De C.VCD. JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Airway Surgical Appliances Ltd.NEPEAN Ontario, CanadaManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Anhui Chuangnuo Medical equipment Co., LTDAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Beocare Inc., HudsonHudson, NC, United StatesManufacturer0000api.fda.gov
C.I.G & Lingerie S.A.SMedellin Antioquia, ColombiaExporter to the US, Manufacturer0000api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.Gebze Kocaeli, TurkeyExporter to the US, Manufacturer0000api.fda.gov
Colowrap LLCChapel Hill, NC, United StatesSpecification developer0000api.fda.gov
Columbus Canvas ProductsColumbus, OH, United StatesManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Core Products International IncChetek, WI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Corflex CaribeSanto Domingo Este, Dominican RepublicComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Dale Medical Products, Inc.New London, CT, United StatesManufacturer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.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, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
DJO TunisiaSfax, TunisiaManufacturer, Repackager or relabeler0000api.fda.gov
DJO TunisieSfax, TunisiaManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Docbrace (cambodia) Co., LtdPhnom Penh Capital, CambodiaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, 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
Dongguan Park Sport Products Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
E.M. Adams De HondurasCHOLOMA Cortes, HondurasManufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesSpecification developer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Frank StubbsOxnard, CA, United StatesManufacturer0000api.fda.gov
Golda, Inc.Beachwood, OH, United StatesSpecification developer0000api.fda.gov
Guangzhou Yifangjia Textile And Garment Technology Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hengshui Xukang Medical Appliances Co., Ltd.Hengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hong Kong Lute Technology Co., LimitedHong Kong, Hong KongForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Huanson Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Hebei Ruinuo Medical Instrument Co LtdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Indaco S.R.L.Filiano Potenza, ItalyManufacturer0000api.fda.gov
Jiangsu Yishun Medical Equipment Co., LtdNantong Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Kang Wen Sports Products(cambodia)co.,ltd.Treang District Takeo, CambodiaContract manufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesManufacturer0000api.fda.gov
Kentron Health Care, Inc.Springfield, TN, United StatesManufacturer0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesContract manufacturer, Specification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Lipoelastic A.S.Prague Praha, Hlavni Mesto, CzechiaManufacturer0000api.fda.gov
Lyssette, S.A. De C.V.Mexico City, MexicoManufacturer0000api.fda.gov
Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)GANANOQUE Ontario, CanadaManufacturer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
My True Image MFG.Richmond, CA, United StatesManufacturer0000api.fda.gov
Nantong Haochuan Industry Co., Ltd.Nantong Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
New Shunta Agora Os3 Corp.Mabalacat City Pampanga, PhilippinesContract manufacturer0000api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Ossur Iceland ehf.Reykjavik, IcelandComplaint file establishment, Specification developer0000api.fda.gov
Pepper Medical, Inc.West Chester, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Power Well Healthcare Technology Co., Ltd.Changhua County, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Promedics Orthopaedic LtdPort Glasgow Scotland, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Qualiteam S.R.L.Burolo Piedmont, ItalyManufacturer0000api.fda.gov
Regina Miracle International (viet Nam) Co., LtdHaiphong Hai Phong, VietnamContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen City U-Lucky Sporting Goods Co., Ltd.Shenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Root Innovation Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Tokyun Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.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
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Caremed Medical Technology Co.,Ltd.shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ta Lai Sporting Goods Enterprises Co. Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Taicang Yigao Medical Technology Co.,ltdTaicang Jiangsu, ChinaManufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Thuasne, LLCManchester, NH, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
United Surgical LLCLaotto, IN, United StatesSpecification developer0000api.fda.gov
United Surgical, Ltd.P.U. Kadda, Gazipur, BangladeshContract manufacturer, Manufacturer0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
WIPRO GE HEALTHCARE PRIVATE Ltd.BANGALORE Karnataka, IndiaSpecification developer0000api.fda.gov
Wipro GE Healthcare Private Ltd.Bangalore Karnataka, IndiaManufacturer0000api.fda.gov
Xiamen Huakang Orthopedic Co.,ltdXiamen City Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated July 20, 1989. 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.