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Data / Medical devices / Splint, Hand, And Components

Splint, Hand, And Components (ILH): 343 FDA-registered makers in 36 countries

343 establishments in 36 countries are registered with the FDA to make Splint, Hand, And Components (product code ILH, Class 1, 21 CFR 890.3475). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on August 1, 1983, 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
ILH
Device class
1
Regulation
890.3475
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China128
United States97
Taiwan23
Vietnam12
Mexico11
India9
Germany8
South Korea6
Pakistan6
Cambodia5
Turkey3
Indonesia3
Dominican Republic2
Spain2
Guatemala2
Latvia2
United Kingdom2
Belgium2
Switzerland2
Bangladesh2
Israel1
Netherlands1
Chile1
Sweden1
Hungary1
Hong Kong1
Brazil1
Italy1
Colombia1
Egypt1
Iceland1
Bulgaria1
Argentina1
Singapore1
Thailand1
Canada1

Makers of Splint, Hand, And Components

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
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Exporter to the US1December 30, 1982000api.fda.gov
Tops Medical Articles Industries Nantong IncQidong City Jiangsu, ChinaManufacturer1December 3, 1982000api.fda.gov
3-Point Products, Inc.Stevensville, MD, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
3M CompanySaint Paul, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
3M Edumex, S.A De C.VCD. JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Acode Sporting Goods Company LimitedHo Chi Minh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Acot Plastics (xiamen) Co., Ltd.XIAMEN Fujian, ChinaContract manufacturer0000api.fda.gov
Actlife Technology Co., Ltd - Thanh Hoa BranchTrung Chinh Commune Thanh Hoa, VietnamManufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Aider Inc.Gangseo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Alimed, LLCDedham, MA, United StatesSpecification developer0000api.fda.gov
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Altochem Co., LtdYongin-Si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Amc Global (cambodia) Co., LtdPhnom Sruoch District Kampong Speu, CambodiaContract manufacturer0000api.fda.gov
Angular Ortho, LLCMequon, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Anji Sanfang Medical Device Co., Ltd.anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Huakang Medical Products FactoryHengshui Hebei, ChinaManufacturer0000api.fda.gov
Apothecary Products, LLC.Burnsville, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Ar Orthopedics, LLCNewberry, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ats InnovationsCookeville, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Atulo ProductsNewton, MA, United StatesManufacturer0000api.fda.gov
Action PackagingWoodstock, IL, United StatesSpecification developer0000api.fda.gov
Anhui Kangfu Industrial Foreign Trade Co.,LtdTianchang Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Argamon Med LTDGivat Yearim Jerusalem, IsraelManufacturer0000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesContract manufacturer0000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, NetherlandsComplaint file establishment, Exporter to the US, Manufacturer, Specification developer0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Benik Corp.Silverdale, WA, United StatesManufacturer0000api.fda.gov
Bestreat Safety & First Aid Solution Co., LtdWuhan Hubei, ChinaManufacturer0000api.fda.gov
Biosculptor CorporationHialeah, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
Braceability, Inc.Cedar Falls, IA, United StatesRepackager or relabeler, Specification developer0000api.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
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bauerfeind USA, INC.Atlanta, GA, United StatesSpecification developer0000api.fda.gov
Bort GmbHWEINSTADT-BENZACH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
BrownmedSpirit Lake, IA, United StatesManufacturer0000api.fda.gov
Camp Scandinavia ABHELSINGBORG Skane, SwedenExporter to the US, Manufacturer0000api.fda.gov
Capital Sports Corporation (pvt) Ltd.Sialkot Punjab, PakistanComplaint file establishment, Manufacturer0000api.fda.gov
Carolina Narrow Fabric Co.Winston-Salem, NC, United StatesContract manufacturer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
China Star Products (binyang) LimitedNanning Guangxi, ChinaManufacturer0000api.fda.gov
Chrisofix Hungary KFT.Budapest, HungaryManufacturer0000api.fda.gov
Comatrix Technology Vietnam Company LimitedHo Chi Minh City, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Comforback IncAuburndale, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Comfort Plus CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Comfortland International, LLCMebane, NC, United StatesSpecification developer0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesSpecification developer0000api.fda.gov
Changshu Sanqiang Accessories Co., Ltd.Changshu Jiangsu, ChinaManufacturer0000api.fda.gov
Darco International, Inc.Huntington, WV, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Dawn Breeze Int'l Trading LimitedWan Chai Hong Kong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
Direcsource LimitedHong Kong, Hong KongContract manufacturer0000api.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
Dong Guan Yunzhishang Health Technology Co.,ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Redthera Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Ruitai Sports Technology Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Well Sport Co LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dynasplint Systems, Inc.Stevensville, MD, United StatesManufacturer0000api.fda.gov
DeRoyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan China Effort Healthcare Products Co., Ltd.Dongguan City Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Chuangguo Daily Products Co.LtdDongguan City, Guangdong, ChinaManufacturer0000api.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 SAVA Sporting Products Co.,LtdDongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongguan Vigor Textile Co.,LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dynamic solution Co., LtdSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesSpecification developer0000api.fda.gov
Edser Insoles S.L.ESPLUGUES DE LLOBREGAT Barcelona, SpainManufacturer0000api.fda.gov
Elastic Therapy, LLCAsheboro, NC, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Emsrun GroupWuxi Jiangsu, ChinaSpecification developer0000api.fda.gov
Fenghua Tealmed Emergency Products Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Fenglin Industry Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Fung Lead Medical & Sports Co., Ltd.Nantou City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Flint Rehabilitation Devices, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamContract manufacturer, Manufacturer0000api.fda.gov
G-Force BracesManchester, NH, United StatesSpecification developer0000api.fda.gov
Gcmedica Enterprise Ltd.(wuxi)WUXI Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Glorious Mercantile Corp. (pvt) Ltd.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Grace And Able I IncSnohomish, WA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Good Time Health Care Products Co., Ltd.Ho Chi Minh City Binh Duong, VietnamContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Guangdong Hexin Technology Weaving Co., LTDHuizhou City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
GuoLong (Shenzhen) High Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Aosi Healthcare Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hartmann Usa Inc.Rock Hill, SC, United StatesSpecification developer0000api.fda.gov
Headstar Medical Products Co., LtdNew Taipei City, TaiwanManufacturer0000api.fda.gov
Health Nuri Co., Ltd.Yeongdeungpo-gu Seoul, South KoreaManufacturer0000api.fda.gov
Hebei Youjie Medical Devices Co., LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.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, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Heptex Industry Company LimitedViet Tri Phu Tho, VietnamExporter to the US, Manufacturer0000api.fda.gov
Hidrolight Do Brasil SAGAROPABA Santa Catarina, BrazilManufacturer0000api.fda.gov
Higgins Supply Co., Inc.McGraw, NY, United StatesManufacturer0000api.fda.gov
Hong Ming Enterprise Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Huiling (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Huntex CorporationTaipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Hely & WeberDfw, TX, United StatesManufacturer, Repackager or relabeler0000api.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
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Indaco S.R.L.Filiano Potenza, ItalyManufacturer0000api.fda.gov
Inmed (wuxi) Medical Device Co.,ltdWuxi Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
IPE Plastic & Hardware Industy, LTDDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Jaeco OrthopedicHot Springs, AR, United StatesManufacturer0000api.fda.gov
Jiangmen Heng Mei Gloves & Decoration Co. Ltd.JIANGMEN Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Excellence Medical Supplies Co., LtdChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Reak Healthy Articles Co.,ltdYangzhong City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Taimedical Technology Co., LtdNanjing Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Xiangyu Fitness Equipment Co., Ltd.Yangzhong Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Yulong Medical Technology Co., Ltd.Yangzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Jiangxi Junhong Sporting Goods Co., Ltd.Ta Khmau Kandal, CambodiaExporter to the US, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Joint Jack CompanyFarmington, CT, United StatesManufacturer0000api.fda.gov
Jiangsu Juneng Sports Goods Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Kaipeng Medical Tech Development Co.,ltdNingBo Zhejiang, ChinaManufacturer0000api.fda.gov
Kamex International S.A.SCajica Cundinamarca, ColombiaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Kang Wen Sports Products(cambodia)co.,ltd.Treang District Takeo, CambodiaManufacturer0000api.fda.gov
Kao Chen Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
KH Best Faith Manufacturing (cambodia) Co., Ltd.Chbar Mon Kampong Speu, CambodiaManufacturer0000api.fda.gov
Kinetec UsaJackson, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Klarity Medical & Equipment (GZ) Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Klarity Medical Products, LLCHeath, OH, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim SirketiSalihli Manisa, TurkeyManufacturer0000api.fda.gov
Kunshan Hi-Fortune Health Products Co., Ltd.Kunshan City, Jiangsu, ChinaManufacturer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Lay Low Enterprises LLCVirginia Beach, VA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Life Wear Technologies, Inc.Pompano Beach, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Lifewear Technologies India Private LimitedSolan Himachal Pradesh, IndiaManufacturer0000api.fda.gov
Lingxian Dongsheng Textile Co., Ltd.Dezhou Shandong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lsez Sia Lauma Medical / Lauma Medical Lsez LLCLiepaja, LatviaContract manufacturer, Manufacturer0000api.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
M2 Global Co., Ltd.Ho Chi Minh City Binh Duong, VietnamExporter to the US, Manufacturer0000api.fda.gov
Mammon International Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Manamed LLCDenton, TX, United StatesSpecification developer0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Mckie Splints, LLCDuluth, MN, United StatesManufacturer0000api.fda.gov
Med2b Ltd.Kitzingen Bavaria, GermanyManufacturer0000api.fda.gov
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
Medical Specialties, Inc.Wadesboro, NC, United StatesManufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
Meed Skills SurgicalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Mobility Braces, LLCNorth Salt Lake, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
More Medical Global Co., LtdTaichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Nanjing Asn Medical Technology Co.,ltdNANJING Jiangsu, ChinaManufacturer0000api.fda.gov
Neo G LimitedKnaresborough North Yorkshire, United KingdomManufacturer0000api.fda.gov
Ningbo Chibanda Imp &exp Co, LtdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Favored Commodity Co.,ltdNINGBO Zhejiang, ChinaRepackager or relabeler, Specification developer0000api.fda.gov
Ningbo First Import & Export Co., Ltd.NINGBO Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Guangbo Medical Technology Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Skyey Industry & Trade Co.ltdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Unico Products Co., LtdNingbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
North Coast Medical, Inc.Morgan Hill, CA, United StatesManufacturer0010api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Ningbo Bolishun Commodity Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Chendong Sports & Sanitarian Co.,ltdNingbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo Troika Science & Technology Co.,Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Nureca Technologies Private LimitedMohali Punjab, IndiaManufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, IncSan Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Orfit Industries NVWIJNEGEM Antwerpen, BelgiumManufacturer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
ORTEC Co., LTD.Busan, South KoreaManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Orthopress Inc.Austin, TX, United StatesManufacturer0000api.fda.gov
Orthoservice AGChiasso Ticino, SwitzerlandManufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Overland Int'l CorporationNew Taipei City, TaiwanExporter 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
Ottobock Manufacturing Bulgaria EOODBlagoevgrad, BulgariaContract manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Paifu Comfort Industrial Co LtdTainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Pantymed S.A.BUENOS AIRES Buenos Aires, Ciudad Autonoma de, ArgentinaManufacturer0000api.fda.gov
Performance Health Supply, LLC.Cedarburg, WI, United StatesManufacturer, Specification developer0000api.fda.gov
Phoenix Instruments, Inc.Lisle, IL, United StatesContract manufacturer0000api.fda.gov
Planet (anhui) Medical Products Co., LtdChuzhou Anhui, ChinaContract manufacturer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Promedics Orthopaedic LtdPort Glasgow Scotland, United KingdomContract manufacturer, Manufacturer0000api.fda.gov
PT. GagacloSemarang Jawa Tengah, IndonesiaManufacturer0000api.fda.gov
Puritan Medical Products Company LLCGuilford, ME, United StatesManufacturer0000api.fda.gov
Qingdao Kunteng Medical Instrument Co LtdJIMOCITY Shandong, ChinaManufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
R&R Medical Corporation Ltd.Sanchong District New Taipei, TaiwanManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Reak Vietnam Company LimitedNhon Trach Commune Dong Nai, VietnamExporter to the US, Manufacturer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Rich Joy Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Richardson Products, Inc.Frankfort, IL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Rival Vietnam Co.,ltdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Roceso Technologies Pte. Ltd.Singapore, West South West, SingaporeManufacturer, Specification developer0000api.fda.gov
Roshung International Co, LimitedQingdao Shandong, ChinaContract manufacturer0000api.fda.gov
Secure Manufacturing (thailand) Co., Ltd.Bangkok Krung Thep Maha Nakhon, ThailandManufacturer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.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 Weprotex Technology Product Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shun Ho (bangladesh) Manufactory LimitedCumilla Zilla Chittagong(Division), BangladeshContract manufacturer0000api.fda.gov
Shun Sze Industrial (shenzhen) Co., LtdSHENZHEN Guangdong, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Sia Tonus Elast / Tonus Elast LLC.Grinvalti,Nicas pag Nicas Novads, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Silver Ring Splint Co.Charlottesville, VA, United StatesManufacturer0000api.fda.gov
Simple Medical (shenzhen) LimitedShenzhen Guangdong, ChinaSpecification developer0000api.fda.gov
Span Link International LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Special Protectors Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
SpentysForest Brussels-Capital Region, BelgiumComplaint file establishment, Specification developer0000api.fda.gov
Splint Factory Corp.Port Townsend, WA, United StatesManufacturer, Specification developer0000api.fda.gov
SPORLASTIC GMBH & Co.KGNURTINGEN Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
STERIS CorporationSaint Louis, MO, United StatesSpecification developer0000api.fda.gov
Sugih Instrumendo Abadi, PTBandung Barat Jawa Barat, IndonesiaManufacturer0000api.fda.gov
Sumec Textile Co.,ltdNanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Suzhou Sunmed Co., LtdSUZHOU CITY Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Care Us Medical Product Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Simple Manufacturing DG LtdDongguan City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Technimen SkillersSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
The China Factory Company LimitedDongguan City Guangdong, ChinaManufacturer0000api.fda.gov
The Soule CoLutz, FL, United StatesManufacturer0000api.fda.gov
Tianjin Tairuibosi Medical Appliance Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Top Longmax Products Co., Ltd.Taichung, TaiwanContract manufacturer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Tenacious Holdings IncSaint Paul, MN, United StatesSpecification developer0000api.fda.gov
Tender CorporationLittleton, NH, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Thuasne, LLCBakersfield, CA, United StatesManufacturer, Specification developer0000api.fda.gov
U.S. Orthotics, Inc.Tampa, FL, United StatesManufacturer0000api.fda.gov
Ulrich AGST. GALLEN Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Uniprox GMBH & Co. KGZeulenroda-Triebes Thuringia, GermanyManufacturer0000api.fda.gov
United Surgical LLCLaotto, IN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
United Surgical, Ltd.P.U. Kadda, Gazipur, BangladeshContract manufacturer, Manufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Vastrade Manufacturing CorporationShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Velcro (china) Fastening Systems Company LimitedZHANGJIAGANG Jiangsu, ChinaContract manufacturer0000api.fda.gov
Velcromex, S.A. De C.V.AGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
VHA Office of Advanced Manufacturing - Ft. LawtonSeattle, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Vietnam Yetitech Equipment Company LimitedN/A Hung Yen, VietnamExporter 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
Wasip Ltd.TORONTO Ontario, CanadaComplaint file establishment, Foreign private label distributor, Manufacturer0000api.fda.gov
Wellpower Sporting Goods Co., Ltd.Dong Guan Guangdong, ChinaContract manufacturer0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Welly Health PBCMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
Wendy Taylor MedeirosPahoa, HI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Winning Industrial Co., Ltd.DONGGUAN Guangdong, ChinaContract manufacturer, Repackager or relabeler0000api.fda.gov
WP Sports (cambodia) Co., Ltd.Bavet City Svay Rieng, CambodiaContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wuxi Fun Gloves Co., LtdWuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer0000api.fda.gov
Wealthy Plastic & Electronic Products Company LimitedHuizhou City Guangdong, ChinaContract manufacturer0000api.fda.gov
Wealthy Plastic & Electronic Products Company LimitedHuizhou City Guangdong, ChinaContract manufacturer0000api.fda.gov
Xiamen Bosegrow Medical Equipment Co.,ltdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen Chengli Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Deland Medical Equipment Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Twe Orthopedics Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xo Armor Technologies IncAuburn, AL, United StatesManufacturer, Specification developer0000api.fda.gov
Xiamen Benli Medical Technology Co., Ltd.Xiamen City Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Feiyali Sporting Goods Co.ltdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangzhou Qionghua Sports Goods Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Sensport Healthcare Supplies Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yangzhou Zhilin Sports Items Co., LtdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Yunbiotech Co.,ltd.Namdong-gu Incheon, South KoreaManufacturer0000api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.YIWU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhangjiagang Jiekang Medical Equipment Co.,ltdZhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangjiagang New Fellow Med Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Aoki Medical Dressing Co., LtdWenzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang KMJK Medical Device Co.,ltdHUZHOU CITY Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Maizi Hosiery Technology Co., LtdYiwu City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Rongrong Hosiery Co LtdYiwu Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhongshan Saxin Electric Heating Technology Co., Ltd.Zhongshan Guangdong, ChinaManufacturer0000api.fda.gov
ZJG Royaltrust Med Co., Ltd.Zhangjiagang City Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Cathaya Health Care Devices Co., Ltd.Huzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Steriger Sports Medicine Technology Co.,LtdYiwu Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated August 1, 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.