Data / Medical devices / Applicator, Absorbent Tipped, Sterile
Applicator, Absorbent Tipped, Sterile (KXG): 174 FDA-registered makers in 25 countries
174 establishments in 25 countries are registered with the FDA to make Applicator, Absorbent Tipped, Sterile (product code KXG, Class 1, 21 CFR 880.6025). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 16, 1980, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- KXG
- Device class
- 1
- Regulation
- 880.6025
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 84 |
| United States | 47 |
| South Korea | 9 |
| Vietnam | 5 |
| Mexico | 3 |
| Germany | 2 |
| Canada | 2 |
| India | 2 |
| Brazil | 2 |
| Malaysia | 2 |
| United Kingdom | 2 |
| Italy | 1 |
| Thailand | 1 |
| Pakistan | 1 |
| Guatemala | 1 |
| Hong Kong | 1 |
| Honduras | 1 |
| Japan | 1 |
| Dominican Republic | 1 |
| Ireland | 1 |
| Netherlands | 1 |
| Australia | 1 |
| Poland | 1 |
| Taiwan | 1 |
| Israel | 1 |
Makers of Applicator, Absorbent Tipped, 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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Across Medical Disposables Co., Ltd. | ANQING Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allcare, Inc. | St Charles, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical Textile Co.,ltd (viet Nam) | Tan Lan Commune Tay Ninh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| An Lanh Investment And Trading Company Limited | Thanh Nam Ward Ninh Binh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Medpurest Medical Technology Co.,ltd | Anqing Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Hongde Medical Products Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Huayong Biotech Co Ltd | Gui Shan Town Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Jiaxin Medical Technology Co., Ltd. | Anqing Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Kangmingna Packaging Co.,ltd | Anqing Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied Medical Resources Corp. | Rsm, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arx Sciences | Amherst, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Dajiang Medical Products Co.,Ltd. | chuzhou Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Applied Medical Distribution Center | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avaline Medical Limited Liability Company | Lakewood, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bandex Industrial Corp. | Zhuhai City Guangdong, China | Contract manufacturer, Exporter to the US, 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 | |
| BGSS Company Asia Limited | Zhabei Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobase Biodustry(shandong)co., Ltd | Jinan Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biodyne | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomed Plastics Co. | Taicang, Jiangsu, China | Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioteke Corporation (wuxi) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Birchwood Laboratories LLC | Eden Prairie, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C-Clear LLC | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha Hunan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Hongtai Paper Film Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Maokang Medical Products Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CITOTEST Labware Manufacturing CO., LTD. | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Citotest Scientific Co.,ltd. | Nanjing Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| COPAN Diagnostics, Inc. | Carlsbad, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Italia | BRESCIA Lombardy, Italy | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Changzhou CareU Medical Instruments Co., Ltd. | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cleanmo (Dongguan) Biotech Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Industries, Inc. | Aguadilla, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Luda Industrial Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shihui Living Products Ltd. | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ebner Medical LLC | Orange Park, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foamtec International Co., Ltd. | Sriracha Chon Buri, Thailand | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fuzhou Delphin Bio-Tech Co., Ltd. | Fuzhou Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauke (hubei) Healthcare Co., Ltd | Huanggang City Hubei, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gfa Production Inc | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GLX Medical Devices Company Limited | Bien Hoa Dong Nai, Vietnam | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gilero, Inc | Pittsboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Medical Production Co. Ltd | JiaXing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodwood Medical Care Ltd | Dalian Liaoning, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| H&K International Trade Limited (china) | jinhua Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haimen Shengbang Laboratory Equipment Co., Ltd | Haimen Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HBH Biotechnology Limited | Yantai Shandong, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henso Medical (hangzhou) Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Histologics LLC | Anaheim, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HLB Co., Ltd. Healthcare | Yeondong-myeon Sejong, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HLB Life Science CO., LTD | Anseong-si Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Kong Lute Technology Co., Limited | Hong Kong, Hong Kong | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huachenyang(shenzhen)technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei V-Medical Products Co., Ltd. | Xiantao Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hynaut Health Technology Co., LTD. | Qingdao Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incore Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPB Inc | Ogden, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Changfeng Medical Industry Co., Ltd | YANGZHOU Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hanheng Medical Technology Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | YANGZHOU CITY, Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjian Medical Apparatus Co., Ltd. | JIANGYAN Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rongye Technology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Senwo Medical Technology Co., Ltd. | Nantong Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jieyang Top-Tip's Daily Use Products Co.,ltd. | JIEYANG Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Manufacturing | Kalamazoo, MI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kriya Medical Technologies Pvt. Ltd. | Kancheepuram Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning City Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kolplast Ci Ltda | Itupeva Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labchem Sdn. Bhd | PETALNG JAYA Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Scantibodies S.A. De C.V. | TECATE Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liaoning Bosen Medical Devices & Technologies Co., Ltd | BenXi Liaoning, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lumiquick Diagnostics, Inc. | Santa Clara, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios Scantibodies, S.A. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Malvern Medical Developments Ltd | WORCESTER Worcestershire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Wire And Equipment Co. Ltd. | Corsham, Wiltshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medico Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miraclean Technology Co., Ltd. | Shenzhen City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MML Diagnostics Packaging, Inc. | Troutdale, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Muling City Long Sen Wood Products Ltd. | Mudanjiang Heilongjiang, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| My Nguyen Viet Nam Co., Ltd | Chau Thanh Commune Vinh Long, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manus Medical, LLC | Henrico, VA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Packaging Corporation | Camarillo, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | shenzhen Guangdong, China | 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 Greetmed Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pmwcorporation | Ulsan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly Medicure Ltd. | Faridabad Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pretium Canada Packaging ULC | ETOBICOKE Ontario, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Procare Industrial Co., Limited | ZHENGZHOU Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Puritan Medical Products, LLC | Pittsfield, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Privapath Diagnostics Ltd | Dublin 11 Dublin(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puritan Medical Products Company, LLC | Pittsfield, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qiagen | Germantown, MD, United States | 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 | |
| Rovers Medical Devices B.V. | OSS Noord-Brabant, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rhinomed Limited | Cremorne Victoria, Australia | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sarstedt AG & Co. KG | NUMBRECHT North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scantibodies Laboratory Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SG BioScience, INC | Dongdaemun-gu Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Haidike Medical Products Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Ruyue Medical Technology Co.,ltd. | Binzhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Fly Medical Devices Co., Ltd. | Minhang District Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Youding International Trade Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shina Med Corporation | Anseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simple Style Inc | Brighton, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Asia Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Medical Poland SP. Z O.O. | Jelcz-Laskowice Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steripack Usa (limited) LLC | Lakeland, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sundex Corporation | Taipei, Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Super Brush LLC | Springfield, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sklar Corporation | Malvern, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taizhou Rich Medical Products Co., Ltd. | TAIZHOU Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trademark Plastics Inc. | Riverside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tribest Dental Products Co Ltd | Yangzhong Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trummed Medical (hangzhou) Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uc-Care | Yokneam Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Us Cotton | Cleveland, OH, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Us Cotton, LLC | Belmont, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| V&Q Manufacturing Corporation | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Medical Plastic JSC | Tam Diep Ward Ninh Binh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Xingtai Packaging Products Co., Ltd. | WeiHai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Nest Biotechnology Co., Ltd | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | weihai Shandong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xcell Therapeutics Inc. | Yongin-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yadu Medical (henan) Co., Ltd | Changyuan Henan, China | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yancheng Huida Medical Instruments Co., Ltd | Yancheng Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yantai Yulong Commodity Co.,ltd. | Yantai Shandong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yocon Biology Technology Company | Haidian Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yong Chang Co., Ltd. | Gimpo Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Microbrush LLC | Grafton, WI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yukon Medical, LLC | Durham, NC, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Kangmin Medical&healthcare Manufacturing Co.,ltd | Lanxi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Gongdong Medical Technology Co., Ltd | TAIZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shuyou Surgical Instrument Co., Ltd | Huzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| bioBoaVista | Valinhos Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 16, 1980. 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.