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.
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
- IQJ
- Device class
- 1
- Regulation
- 890.3490
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 28 |
| United States | 21 |
| Taiwan | 12 |
| India | 8 |
| Mexico | 6 |
| Cambodia | 3 |
| Vietnam | 2 |
| Guatemala | 2 |
| United Kingdom | 2 |
| Turkey | 2 |
| Canada | 1 |
| Dominican Republic | 1 |
| Chile | 1 |
| Germany | 1 |
| Sweden | 1 |
| Egypt | 1 |
| South Korea | 1 |
| Iceland | 1 |
| Spain | 1 |
| France | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3M Company | Saint Paul, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abletech Orthopedics Corporation | New Taipei City Taiwan, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airway Surgical Appliances Ltd. | NEPEAN Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alex Orthopedic, Inc. | Grand Prairie, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmay Bodywear (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amc Global (cambodia) Co., Ltd | Phnom Sruoch District Kampong Speu, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| AccuMed Corp. | Nigua San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bird & Cronin, LLC | Eagan, MN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg Mexico, S. De R.L. De C.V. (3) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg Mexico, S. De R.L. De C.V. (4) | Mexicali Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN Medical GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN Medical S.A. de C.V. | Reynosa Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Camp Scandinavia AB | HELSINGBORG Skane, Sweden | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Darco International, Inc. | Huntington, WV, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Docbrace (cambodia) Co., Ltd | Phnom Penh Capital, Cambodia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Nan You Sporting Goods Enterprise Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Supercare Medical Products Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Techno Medicals Private Limited | Coimbatore Tamil Nadu, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Park Sport Products Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Vigor Textile Co.,Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E-Life International Co., Ltd | Yonghe Dist., Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elastic Therapy, LLC | Asheboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Company Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Titan Smart Electrical Appliance Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Weize Imp & Exp Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hing Ka Yuen Health Technology (changzhou )co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntex Corporation | Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Dacheng Medical Technology Co., LTD. | XianNing City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Ming Sanitary Materials Co., Ltd. | Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaipeng Medical Tech Development Co.,ltd | NingBo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenad SG Medical, Inc. | Bartlett, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Pointique International Ltd. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liang Cheng Sporting Goods Company Limited | Ben Cat Ward Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liven Sports MFG. (xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lu Lu Sports Corp. | Nantou City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S. Ascent Meditech Limited | GOREGAON (E) Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MD Orthopaedics | Wayland, IA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medex Medical Supplies Ltd. | China Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MGRM Medicare Ltd. | Khairatabad, Hyderabad Andhra Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neo G Limited | Knaresborough North Yorkshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neomed Co., Ltd. | Saha-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthotech Rehabilitation Co., Ltd. | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho and Surgical Products Enterprises S.A. | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur Iceland ehf. | Reykjavik, Iceland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P.C.P. Champion | Ripley, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paifu Comfort Industrial Co Ltd | Tainan City, Taiwan | Contract manufacturer, Contract sterilizer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pelvic Binder, Inc. | Cumby, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plus Meditech Co., Ltd. Plant 2 | Tainan City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Well Healthcare Technology Co., Ltd. | Changhua County, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prim,s.a. | Mostoles Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promedics Orthopaedic Ltd | Port Glasgow Scotland, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protect3d, Inc. | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rich Joy Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ryder Pet Supplies (cambodia)co., Ltd | Sihanouk Preah Sihanouk, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen City U-Lucky Sporting Goods Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPM Medicare Pvt, Ltd. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Appliance Industries, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Leison Medical & Healthcare Products Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne SAS | SAINT ETIENNE Hauts-de-Seine, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tien Jiang Enterprise Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Orthotics, Inc. | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd Sti | KUCUKCEKMECE Istanbul, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variteks Ortopedi Sanayi A.S. | Catalca Istanbul, Turkey | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welltex Sports Co., Ltd. | Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Deland Medical Equipment Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Huakang Orthopedic Co.,ltd | Xiamen City Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Ortocare Sports Health Co.,ltd. | Xiamen Free Trade Zone Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangpu Ortholife Rehabilitation Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangzhou Recaring Medical Instrument Co., Ltd | Zhangzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.