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Data / Medical devices / Splint, Clavicle

Splint, Clavicle (IQJ): 96 FDA-registered makers in 20 countries

96 establishments in 20 countries are registered with the FDA to make Splint, Clavicle (product code IQJ, Class 1, 21 CFR 890.3490). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on January 14, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IQJ
Device class
1
Regulation
890.3490
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China28
United States21
Taiwan12
India8
Mexico6
Cambodia3
Vietnam2
Guatemala2
United Kingdom2
Turkey2
Canada1
Dominican Republic1
Chile1
Germany1
Sweden1
Egypt1
South Korea1
Iceland1
Spain1
France1

Makers of Splint, Clavicle

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 StatesSpecification developer0000api.fda.gov
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Airway Surgical Appliances Ltd.NEPEAN Ontario, CanadaManufacturer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Amc Global (cambodia) Co., LtdPhnom Sruoch District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
AccuMed Corp.Nigua San Cristobal, Dominican RepublicContract manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (3)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (4)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
BSN Medical GmbHHamburg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
Camp Scandinavia ABHELSINGBORG Skane, SwedenExporter to the US, Manufacturer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.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
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.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
Dongguan Vigor Textile Co.,LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesSpecification developer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Guangdong Titan Smart Electrical Appliance Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hing Ka Yuen Health Technology (changzhou )co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Hebei Ruinuo Medical Instrument Co LtdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter 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 Dacheng Medical Technology Co., LTD.XianNing City Hubei, ChinaContract manufacturer0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Kaipeng Medical Tech Development Co.,ltdNingBo Zhejiang, ChinaManufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesManufacturer0000api.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
Linjiang (holdings) LimitedShangqiu Henan, ChinaForeign private label distributor, Manufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lu Lu Sports Corp.Nantou City, TaiwanContract 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
MD OrthopaedicsWayland, IA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.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
Neo G LimitedKnaresborough North Yorkshire, United KingdomManufacturer0000api.fda.gov
Neomed Co., Ltd.Saha-gu Busan, South KoreaManufacturer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.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
P.C.P. ChampionRipley, OH, United StatesManufacturer0000api.fda.gov
Paifu Comfort Industrial Co LtdTainan City, TaiwanContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Pelvic Binder, Inc.Cumby, TX, United StatesManufacturer0000api.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
Prim,s.a.Mostoles Madrid(Province), SpainManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
Promedics Orthopaedic LtdPort Glasgow Scotland, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Protect3d, Inc.Durham, NC, United StatesManufacturer0000api.fda.gov
Rich Joy Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Ryder Pet Supplies (cambodia)co., LtdSihanouk Preah Sihanouk, CambodiaManufacturer0000api.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, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.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
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Thuasne SASSAINT ETIENNE Hauts-de-Seine, FranceManufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.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
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Xiamen Deland Medical Equipment Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Huakang Orthopedic Co.,ltdXiamen City Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Sensport Healthcare Supplies Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated January 14, 1983. 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.