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Data / Medical devices / Splint, Extremity, Non-Inflatable, External, Non-Sterile

Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC): 131 FDA-registered makers in 22 countries

131 establishments in 22 countries are registered with the FDA to make Splint, Extremity, Non-Inflatable, External, Non-Sterile (product code NOC, Class 1, 21 CFR 878.3910). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (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
NOC
Device class
1
Regulation
878.3910
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
China53
United States38
Taiwan6
South Korea6
Mexico3
United Kingdom3
India3
Cambodia2
Germany2
Canada2
Turkey2
Sweden1
Slovakia1
Vietnam1
Israel1
Brazil1
Malaysia1
Egypt1
Finland1
Iceland1
Thailand1
Italy1

Makers of Splint, Extremity, Non-Inflatable, External, Non-Sterile

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
A & I Industries LtdFOSHAN CITY Guangdong, ChinaManufacturer0000api.fda.gov
AB Germa,swedenKRISTIANSTAD Skane, SwedenManufacturer0000api.fda.gov
Aero HealthcareValley Cottage, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Alimed, LLCDedham, MA, United StatesManufacturer0000api.fda.gov
AlphapointeKansas City, MO, United StatesManufacturer0000api.fda.gov
Amc Global (cambodia) Co., LtdPhnom Sruoch District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ActivArmorPort Saint Lucie, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Airflo (Xiamen) Medical Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
BECON MEDICAL Ltd.Batavia, IL, United StatesSpecification developer0000api.fda.gov
Beijing Health Medical Technology Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaManufacturer0000api.fda.gov
Blessing Cathay CorporationNew Taipei City, TaiwanManufacturer0000api.fda.gov
BSN Medical GmbHHamburg, GermanyComplaint file establishment, 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
Cambridge Ortopaedic Labs LtdMarket Harborough Leicester, United KingdomComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Carolina Narrow Fabric Co.Winston-Salem, NC, United StatesSpecification developer0000api.fda.gov
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.Chengdu Sichuan, ChinaManufacturer0000api.fda.gov
Comebetter (guangzhou) Technology Co., LtdGuangzhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Comfort Plus CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Dick Medical SupplyColumbus, OH, United StatesManufacturer0000api.fda.gov
DIMENSION ORTHO Inc.Philadelphia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongyang City Yonoel Outdoor Products Co.,ltdDongyang Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, 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
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer0000api.fda.gov
Emsrun GroupWuxi Jiangsu, ChinaSpecification developer0000api.fda.gov
EarGear LLCEden Prairie, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Emergency Products & Research, Inc.Kent, OH, United StatesManufacturer0000api.fda.gov
Essentia Industries Ltd.Dong Guan Guangdong, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Faretec, Inc.Painesville, OH, United StatesManufacturer0000api.fda.gov
Ferno Canada, Inc.Oakville Ontario, CanadaExporter to the US, Specification developer0000api.fda.gov
Ferno-Washington, Inc.Wilmington, OH, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ferno Slovakia s.r.o.Slovak Republic Trenciansky, SlovakiaComplaint file establishment, Manufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
G Surgiwear LimitedShahjahanpur Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Garware Healthcare India Pvt LtdSatara Maharashtra, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Gauke (hubei) Healthcare Co., LtdHuanggang City Hubei, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Gero3d LtdTel Aviv-Yafo Central, IsraelManufacturer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Guangdong Meicen Medical Equipment Co., Ltd.foshan Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou New Design Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Garware Fulflex USA Inc. (previously AVCOR Health Care Products, Inc.)Fort Worth, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Health Nuri Co., Ltd.Yeongdeungpo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Heitco, Inc.Avon, OH, United StatesContract manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Runde Medical Instruments Co.,ltdHengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hengshui Tianjian Medical Supplies Co., Ltd.ShenZhou City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hengshui Xukang Medical Appliances Co., Ltd.Hengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hidrolight Do Brasil SAGAROPABA Santa Catarina, BrazilManufacturer0000api.fda.gov
Hong Ming Enterprise Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Heaven Healthcare Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer0000api.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
Hubei Dacheng Medical Technology Co., LTD.XianNing City Hubei, ChinaContract manufacturer0000api.fda.gov
I.V. HouseSaint Louis, MO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Immco Diagnostics, Inc.Williamsville, NY, United StatesManufacturer0000api.fda.gov
Invictus Global LimitedSWADLINCOTE Derbyshire, United KingdomManufacturer0000api.fda.gov
Jiangsu Saikang Medical Equipment Co., LtdZhangjiagang Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Senolo Medical Technology Co., Ltd.Yancheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Yangtze River Medical Technology Corp.Taizhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yongfa Medical Equipment Technology Co., LtdZhangjiagang City Jiangsu, ChinaManufacturer0000api.fda.gov
Join Enterprise, Ltd.Yongin-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Kang Wen Sports Products(cambodia)co.,ltd.Treang District Takeo, CambodiaManufacturer0000api.fda.gov
Kentec Medical, LLCIrvine, CA, United StatesSpecification developer0000api.fda.gov
LKL Advance Metaltech Sdn BhdSeri Kembangan Selangor, MalaysiaManufacturer0000api.fda.gov
Medsource Factory,inc.CHANGZHOU Jiangsu, ChinaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptManufacturer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
McARTHUR MEDICAL SALES, INC.Rockton, Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
ORTEC Co., LTD.Busan, South KoreaManufacturer0000api.fda.gov
OY Primo Finland ABVaasa Pohjanmaa, FinlandContract manufacturer, Repackager or relabeler0000api.fda.gov
Ossur Iceland ehf.Reykjavik, IcelandComplaint file establishment, Specification developer0000api.fda.gov
Puli Healthcare (thailand) Co., Ltd.Bangkok Samut Prakan, ThailandExporter to the US, Manufacturer0000api.fda.gov
Posey, S. de R.L. de C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
RED MEDICAL CORPORATION dba Med Tech Sweden Inc (Unit # 4, 3 and Office)Geneseo, IL, United StatesManufacturer0000api.fda.gov
Redicare LLCCongers, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Safeguard Medical Technologies LtdHereford Herefordshire, United KingdomSpecification developer0000api.fda.gov
Safeguard Us Operating, LLCHuntersville, NC, United StatesManufacturer0000api.fda.gov
Sam Medical ProductsTualatin, OR, United StatesManufacturer0000api.fda.gov
Shandong Yabin Medical Technology Co., LtdZibo Shandong, ChinaManufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
Shanghai No. 2 Medical College Duhang Medical Equipment FactoryShanghai, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Shenyang Ourpromise Medical Equipment Co., Ltd.Shenyang Liaoning, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shenzhen Weprotex Technology Product Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Spencer Italia SRLSala Baganza Parma, ItalyManufacturer0000api.fda.gov
Stroke Holder Inc.Las Vegas, NV, United StatesSpecification developer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
SunmedicaRedding, CA, United StatesManufacturer0000api.fda.gov
Suzhou Pulikang Medical Device Co LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Suzhou Sunmed Co., LtdSUZHOU CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shijiazhuang Yide Medical Device Manufacturing Co., Ltd.Shijiazhuang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Suzhou Meccan Import and Export Corp.Suzhou Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Taizhou Xinkang Medical Materials Co., LtdTaizhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Talexmedical, LLCMalvern, PA, United StatesManufacturer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
The Medi-Kid Co., Inc.Hemet, CA, United StatesManufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesSpecification developer0000api.fda.gov
Tomocross International Co., LtdTaichung City, TaiwanContract manufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Tri-Tech Forensics, Inc.Leland, NC, United StatesManufacturer, Specification developer0000api.fda.gov
Tuper Medical Co., Ltd.Dezhou City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Tender CorporationLittleton, NH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Tomato M&C Co.,LtdPyeongtaek-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.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
Woosam Medical Co., Ltd.Paju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
X-CEN-TEK GmbH & Co. KGWardenburg Lower Saxony, GermanyManufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Yiwu Kebon Healthcare Co., Ltd.Yiwu Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Yoorim Corp.EUMSEONG-GUN Chungbuk, South KoreaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhongshan A&e Machinery Industry Co., LtdZhongshan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan A&j Medical Equipment Co., Ltd.Guangdong, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.