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
| Country | Makers |
|---|---|
| China | 128 |
| United States | 97 |
| Taiwan | 23 |
| Vietnam | 12 |
| Mexico | 11 |
| India | 9 |
| Germany | 8 |
| South Korea | 6 |
| Pakistan | 6 |
| Cambodia | 5 |
| Turkey | 3 |
| Indonesia | 3 |
| Dominican Republic | 2 |
| Spain | 2 |
| Guatemala | 2 |
| Latvia | 2 |
| United Kingdom | 2 |
| Belgium | 2 |
| Switzerland | 2 |
| Bangladesh | 2 |
| Israel | 1 |
| Netherlands | 1 |
| Chile | 1 |
| Sweden | 1 |
| Hungary | 1 |
| Hong Kong | 1 |
| Brazil | 1 |
| Italy | 1 |
| Colombia | 1 |
| Egypt | 1 |
| Iceland | 1 |
| Bulgaria | 1 |
| Argentina | 1 |
| Singapore | 1 |
| Thailand | 1 |
| Canada | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Exporter to the US | 1 | December 30, 1982 | 0 | 0 | 0 | api.fda.gov |
| Tops Medical Articles Industries Nantong Inc | Qidong City Jiangsu, China | Manufacturer | 1 | December 3, 1982 | 0 | 0 | 0 | api.fda.gov |
| 3-Point Products, Inc. | Stevensville, MD, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 3M Company | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 3M Edumex, S.A De C.V | CD. JUAREZ Chihuahua, Mexico | Manufacturer | 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 | |
| Acode Sporting Goods Company Limited | Ho Chi Minh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acot Plastics (xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Actlife Technology Co., Ltd - Thanh Hoa Branch | Trung Chinh Commune Thanh Hoa, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aid United International Co., Limited | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aider Inc. | Gangseo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Air A Med, LLC | Fort Myers, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akervall Technologies | Saline, MI, United States | Complaint file establishment, Contract manufacturer, 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 | |
| Alimed, LLC | Dedham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmay Bodywear (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altochem Co., Ltd | Yongin-Si Gyeonggi, South Korea | 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 | |
| Angular Ortho, LLC | Mequon, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Sanfang Medical Device Co., Ltd. | anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anping Guardian Medical Equipment Co.,ltd | Hengshui Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anping Huakang Medical Products Factory | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecary Products, LLC. | Burnsville, MN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ar Orthopedics, LLC | Newberry, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ats Innovations | Cookeville, TN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atulo Products | Newton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Action Packaging | Woodstock, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Kangfu Industrial Foreign Trade Co.,Ltd | Tianchang Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argamon Med LTD | Givat Yearim Jerusalem, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barbaras Development, Inc. | Thousand Oaks, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Basko Healthcare B.V. | ZAANDAM Noord-Holland, Netherlands | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becker Orthopedic Appliance Co. | Troy, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang City Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benik Corp. | Silverdale, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bestreat Safety & First Aid Solution Co., Ltd | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biosculptor Corporation | Hialeah, FL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bird & Cronin, LLC | Eagan, MN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braceability, Inc. | Cedar Falls, IA, United States | Repackager or relabeler, Specification developer | 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 | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bauerfeind USA, INC. | Atlanta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bort GmbH | WEINSTADT-BENZACH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brownmed | Spirit Lake, IA, United States | 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 | |
| Capital Sports Corporation (pvt) Ltd. | Sialkot Punjab, Pakistan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carolina Narrow Fabric Co. | Winston-Salem, NC, United States | Contract 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 | |
| China Star Products (binyang) Limited | Nanning Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chrisofix Hungary KFT. | Budapest, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comatrix Technology Vietnam Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comforback Inc | Auburndale, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Plus Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfortland International, LLC | Mebane, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products Intl., Inc. | Osceola, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changshu Sanqiang Accessories Co., Ltd. | Changshu Jiangsu, China | 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 | |
| Dawn Breeze Int'l Trading Limited | Wan Chai Hong Kong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 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 | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Direcsource Limited | Hong Kong, Hong Kong | Contract manufacturer | 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 | |
| Dong Guan Yunzhishang Health Technology Co.,ltd. | Dongguan City Guangdong, China | 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 Redthera Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Ruitai Sports Technology Co., Ltd | Dongguan Guangdong, China | Exporter to the US, 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 | |
| Dongguan Well Sport Co Ltd | Dongguan Guangdong, China | Contract 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 | |
| Dynasplint Systems, Inc. | Stevensville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DeRoyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Chuangguo Daily Products Co.Ltd | Dongguan City, Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, 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 SAVA Sporting Products Co.,Ltd | Dongguan City Guangdong, China | Contract manufacturer, 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 | |
| Dynamic solution Co., Ltd | Seongnam-si Gyeonggi, South Korea | 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 | |
| E. Bac Si Imports LLC | Ellensburg, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edser Insoles S.L. | ESPLUGUES DE LLOBREGAT Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elastic Therapy, LLC | Asheboro, NC, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emsrun Group | Wuxi Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenghua Tealmed Emergency Products Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenglin Industry Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Company Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fung Lead Medical & Sports Co., Ltd. | Nantou City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flint Rehabilitation Devices, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| G-Force Braces | Manchester, NH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Glorious Mercantile Corp. (pvt) Ltd. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grace And Able I Inc | Snohomish, WA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Time Health Care Products Co., Ltd. | Ho Chi Minh City Binh Duong, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greenwood Marketing LLC | Brandenburg, KY, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Hexin Technology Weaving Co., LTD | Huizhou City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GuoLong (Shenzhen) High Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Aosi Healthcare Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, 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 | |
| Hartmann Usa Inc. | Rock Hill, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Headstar Medical Products Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Nuri Co., Ltd. | Yeongdeungpo-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Youjie Medical Devices Co., Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Runde Medical Instruments Co.,ltd | Hengshui City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Tianjian Medical Supplies Co., Ltd. | ShenZhou City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Xukang Medical Appliances Co., Ltd. | Hengshui City Hebei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heptex Industry Company Limited | Viet Tri Phu Tho, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hidrolight Do Brasil SA | GAROPABA Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Higgins Supply Co., Inc. | McGraw, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Ming Enterprise Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huiling (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntex Corporation | Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hely & Weber | Dfw, TX, United States | Manufacturer, Repackager or relabeler | 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 | |
| Ideavillage Products Corp. | Wayne, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indaco S.R.L. | Filiano Potenza, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inmed (wuxi) Medical Device Co.,ltd | Wuxi Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPE Plastic & Hardware Industy, LTD | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instrumed International Inc dba Avalign German Specialty Instruments | Schaumburg, IL, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jaeco Orthopedic | Hot Springs, AR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangmen Heng Mei Gloves & Decoration Co. Ltd. | JIANGMEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Excellence Medical Supplies Co., Ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | YANGZHOU CITY, Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Reak Healthy Articles Co.,ltd | Yangzhong City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Taimedical Technology Co., Ltd | Nanjing Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Xiangyu Fitness Equipment Co., Ltd. | Yangzhong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yulong Medical Technology Co., Ltd. | Yangzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Junhong Sporting Goods Co., Ltd. | Ta Khmau Kandal, Cambodia | Exporter to the US, 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 | |
| Joint Jack Company | Farmington, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Juneng Sports Goods Technology Co., Ltd | Yangzhou Jiangsu, China | 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 | |
| Kamex International S.A.S | Cajica Cundinamarca, Colombia | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kang Wen Sports Products(cambodia)co.,ltd. | Treang District Takeo, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kao Chen Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenad SG Medical, Inc. | Bartlett, TN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| KH Best Faith Manufacturing (cambodia) Co., Ltd. | Chbar Mon Kampong Speu, Cambodia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kinetec Usa | Jackson, WI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klarity Medical Products, LLC | Heath, OH, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi | Salihli Manisa, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan City, Jiangsu, China | 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 | |
| Lay Low Enterprises LLC | Virginia Beach, VA, United States | Complaint file establishment, 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 | |
| Life Wear Technologies, Inc. | Pompano Beach, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifewear Technologies India Private Limited | Solan Himachal Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Contract manufacturer, Exporter to the US, 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 | |
| Lsez Sia Lauma Medical / Lauma Medical Lsez LLC | Liepaja, Latvia | Contract manufacturer, 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 | |
| M2 Global Co., Ltd. | Ho Chi Minh City Binh Duong, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mammon International Corp. | Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manamed LLC | Denton, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mckie Splints, LLC | Duluth, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med2b Ltd. | Kitzingen Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medex Medical Supplies Ltd. | China Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Specialties, Inc. | Wadesboro, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medicon, E.G. | TUTTLINGEN Baden-Wurttemberg, Germany | 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 | |
| Medtech Acuna S.A. De C.V. | Acuna Coahuila, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meed Skills Surgical | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MGRM Medicare Ltd. | Khairatabad, Hyderabad Andhra Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Orthopedics Inc. | Arlington, TN, United States | Repackager or relabeler, Specification developer | 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 | |
| Mobility Braces, LLC | North Salt Lake, UT, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| More Medical Global Co., Ltd | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Multi Garmen Indonesia | BOGOR Jawa Barat, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nanjing Asn Medical Technology Co.,ltd | NANJING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neo G Limited | Knaresborough North Yorkshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chibanda Imp &exp Co, Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Favored Commodity Co.,ltd | NINGBO Zhejiang, China | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo First Import & Export Co., Ltd. | NINGBO Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Guangbo Medical Technology Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo MPF Manufacturing Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo, Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Skyey Industry & Trade Co.ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Tianbo First Aid Product Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Unico Products Co., Ltd | Ningbo Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| North Coast Medical, Inc. | Morgan Hill, CA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| NYOrtho | Brooklyn, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Bolishun Commodity Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Chendong Sports & Sanitarian Co.,ltd | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Troika Science & Technology Co.,Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nureca Technologies Private Limited | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc | San Pedro De Macoris, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orfit Industries NV | WIJNEGEM Antwerpen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orliman Slu | La Pobla de Vallbona Valencia(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ORTEC Co., LTD. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthopress Inc. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthoservice AG | Chiasso Ticino, Switzerland | Manufacturer | 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 | |
| Overland Int'l Corporation | New Taipei City, Taiwan | 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 | |
| Ottobock Manufacturing Bulgaria EOOD | Blagoevgrad, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paifu Comfort Industrial Co Ltd | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pantymed S.A. | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Health Supply, LLC. | Cedarburg, WI, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Planet (anhui) Medical Products Co., Ltd | Chuzhou Anhui, China | Contract 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 | |
| Preferred Industries, Inc. | Fort Lauderdale, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promedics Orthopaedic Ltd | Port Glasgow Scotland, United Kingdom | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Gagaclo | Semarang Jawa Tengah, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Kunteng Medical Instrument Co Ltd | JIMOCITY Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R&R Medical Corporation Ltd. | Sanchong District New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reak Vietnam Company Limited | Nhon Trach Commune Dong Nai, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Restorative Care Of America, Inc. | Saint Petersburg, FL, 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 | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rival Vietnam Co.,ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roceso Technologies Pte. Ltd. | Singapore, West South West, Singapore | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roshung International Co, Limited | Qingdao Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secure Manufacturing (thailand) Co., Ltd. | Bangkok Krung Thep Maha Nakhon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secured Ortho Manufacturing Of America, LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 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 | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Weprotex Technology Product Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Ho (bangladesh) Manufactory Limited | Cumilla Zilla Chittagong(Division), Bangladesh | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Sze Industrial (shenzhen) Co., Ltd | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sia Tonus Elast / Tonus Elast LLC. | Grinvalti,Nicas pag Nicas Novads, Latvia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Silver Ring Splint Co. | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simple Medical (shenzhen) Limited | Shenzhen Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span Link International LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Special Protectors Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spentys | Forest Brussels-Capital Region, Belgium | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Splint Factory Corp. | Port Townsend, WA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPORLASTIC GMBH & Co.KG | NURTINGEN Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STERIS Corporation | Saint Louis, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sugih Instrumendo Abadi, PT | Bandung Barat Jawa Barat, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sumec Textile Co.,ltd | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Sunmed Co., Ltd | SUZHOU CITY Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai, China | Exporter to the US, 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 | |
| Shijiazhuang Aofeite Medical Device Co.,Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simple Manufacturing DG Ltd | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The China Factory Company Limited | Dongguan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Soule Co | Lutz, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, CA, United States | 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 | |
| Top Longmax Products Co., Ltd. | Taichung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Shelf Manufacturing, LLC | Tracy, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trend Medical, LLC | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tenacious Holdings Inc | Saint Paul, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tender Corporation | Littleton, NH, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne, LLC | Bakersfield, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Orthotics, Inc. | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ulrich AG | ST. GALLEN Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uniprox GMBH & Co. KG | Zeulenroda-Triebes Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical LLC | Laotto, IN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Surgical, Ltd. | P.U. Kadda, Gazipur, Bangladesh | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vastrade Manufacturing Corporation | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcro (china) Fastening Systems Company Limited | ZHANGJIAGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcromex, S.A. De C.V. | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VHA Office of Advanced Manufacturing - Ft. Lawton | Seattle, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Yetitech Equipment Company Limited | N/A Hung Yen, Vietnam | Exporter to the US, 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 | |
| Wasip Ltd. | TORONTO Ontario, Canada | Complaint file establishment, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellpower Sporting Goods Co., Ltd. | Dong Guan Guangdong, China | Contract 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 | |
| Welly Health PBC | Minneapolis, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wendy Taylor Medeiros | Pahoa, HI, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Winning Industrial Co., Ltd. | DONGGUAN Guangdong, China | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| WP Sports (cambodia) Co., Ltd. | Bavet City Svay Rieng, Cambodia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Fun Gloves Co., Ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wealthy Plastic & Electronic Products Company Limited | Huizhou City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wealthy Plastic & Electronic Products Company Limited | Huizhou City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Bosegrow Medical Equipment Co.,ltd | Xiamen Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Chengli Medical Equipment Co., Ltd. | Xiamen Fujian, China | Manufacturer | 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 J-Brace Medical Equipment Co., Ltd. | Xiamen Fujian, China | 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 | |
| Xiamen Twe Orthopedics Co., Ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xo Armor Technologies Inc | Auburn, AL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Benli Medical Technology Co., Ltd. | Xiamen City Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Feiyali Sporting Goods Co.ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Qionghua Sports Goods Co.,ltd | Yangzhou Jiangsu, 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 | |
| Yangzhou Zhilin Sports Items Co., Ltd | Yangzhou Jiangsu, China | Exporter to the US, 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 | |
| Yunbiotech Co.,ltd. | Namdong-gu Incheon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Ori-Power Medtech Co., Ltd. | YIWU Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Jiekang Medical Equipment Co.,ltd | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang New Fellow Med Co., Ltd. | Zhangjiagang Jiangsu, China | 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 Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Aoki Medical Dressing Co., Ltd | Wenzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang KMJK Medical Device Co.,ltd | HUZHOU CITY Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Maizi Hosiery Technology Co., Ltd | Yiwu City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Rongrong Hosiery Co Ltd | Yiwu Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Saxin Electric Heating Technology Co., Ltd. | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZJG Royaltrust Med Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeffer Research & Assoc. S. A. de C. V. | Ensenada Baja California, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Cathaya Health Care Devices Co., Ltd. | Huzhou Zhejiang, China | Contract 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 | |
| Zhejiang Steriger Sports Medicine Technology Co.,Ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.