Data / Medical devices / Cover, Mattress (Medical Purposes)
Cover, Mattress (Medical Purposes) (FMW): 175 FDA-registered makers in 25 countries
175 establishments in 25 countries are registered with the FDA to make Cover, Mattress (Medical Purposes) (product code FMW, Class 1, 21 CFR 880.6190). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 20, 2016, and lists 3 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
- FMW
- Device class
- 1
- Regulation
- 880.6190
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| China | 77 |
| United States | 48 |
| Canada | 8 |
| Taiwan | 7 |
| Malaysia | 4 |
| Mexico | 4 |
| Vietnam | 3 |
| South Korea | 3 |
| Turkey | 2 |
| India | 2 |
| El Salvador | 2 |
| Pakistan | 2 |
| Japan | 1 |
| Chile | 1 |
| Sweden | 1 |
| Netherlands | 1 |
| United Kingdom | 1 |
| Estonia | 1 |
| Spain | 1 |
| Bangladesh | 1 |
| Cambodia | 1 |
| Switzerland | 1 |
| Philippines | 1 |
| Colombia | 1 |
| Germany | 1 |
Makers of Cover, Mattress (Medical Purposes)
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 |
|---|---|---|---|---|---|---|---|---|
| Precision Fabrics Group, Inc. | Greensboro, NC, United States | Manufacturer | 1 | January 25, 2007 | 0 | 0 | 0 | api.fda.gov |
| 2712218 Ontario Inc | Concord Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| 5 Minds Mobility | Oshawa Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Tekniko | Lake Zurich, IL, United States | 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 | |
| Anhui Ares Medical Technology Co.,ltd. | Tianchang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui JM Healthcare Products Co.,ltd. | Shouxian Anhui, China | 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 | |
| Ari Medical Technology Co., Ltd. | Hefei Anhui, China | Manufacturer | 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 | |
| Atom Medical Corporation | Sakura-ku, Saitama-shi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Agiliti Health - Corona | Corona, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beck's Classic | Brentwood, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | 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 | |
| Care Line, Inc. | Greenbrier, TN, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Casco Manufacturing Solutions, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changshu Welland Textiles Co.,ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Care-De Sanitary Material Co., Ltd | Changzhou Jiangsu, China | Contract manufacturer, 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 Newrise Medical & Hygiene Products Co., Ltd | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Confitex Apparel Technology Co. Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cognito Health Inc. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dalian Rongbang Medical Healthy Devices Co Ltd | Dalian Liaoning, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Derby Industries | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Mingfu Industry Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan China Effort Healthcare Products Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Encompass Group, LLC. | McDonough, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essity Canada Inc. | DRUMMONDVILLE Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essity HMS North America Inc. | Bowling Green, KY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essity Hygiene and Health AB | Gothenburg Vastra Gotaland, Sweden | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Essity Operations Gennep B.V. | GENNEP Limburg, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frontier Therapeutics Limited | Tredegar Blaenau Gwent, United Kingdom | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujian Quanzhoucity Aile Hygiene Products Co.,ltd. | Nanan City Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujian Time And Tianhe Industrial Co., Ltd | Nanan Fujian, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Future Foam Inc | E Providence, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gentug Tekstil Urunleri A.S. | Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| George Courey Inc | Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc | Atlanta, GA, United States | Manufacturer | 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 | |
| Greatcare 4u Sdn Bhd | Selangor Darul Ehsan, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Green Energy Nano Technology Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Junfeng BFS Technology Co., Ltd. | guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Yazhi Technology Co., Ltd | Huizhou City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Yuehua Medical Instrument Factory Co., Ltd. | Shantou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Baoli Hardware & Electronic Co.,ltd. | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gabriel Scientific OU | Parnu linn Parnumaa, Estonia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greenwood Marketing LLC - Indy | Plainfield, IN, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haining Hengshang Knitting Co., Ltd | JIAXING Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haining Meike Textile Co.,ltd. | Haining Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haining Yikang Textile Co., Ltd | Haining Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Alline Plastic Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Musen Import And Export Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Webian Medical Instrument Trading Co., Ltd | SHIJIAZHUANG CITY Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei MT Medical Co.,ltd. | Hefei Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Joinkona Medical Products Stock Co.,ltd | Pingdingshan Henan, China | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Life Technology (hebei) Co.,ltd. | Bazhou Hebei, China | Exporter to the US, 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 | |
| Honghu Danielle Sanitary Material Co., Ltd. | Honghu City Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hot & Hot Co., Ltd. | Namyangju-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer, Repackager or relabeler | 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 | |
| Heye Health Technology Co., Ltd. | HuZhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Haixin Protective Products Group Co.,Ltd | Songzi City Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICARE MEDICAL GROUP USA, Inc | Gothenburg, NE, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icat S.A. De C.V. | San Salvador, El Salvador | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Improving Mobility Development SL | LLIRIA Valencia(Province), Spain | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Medcraft LLC | East Hampton, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Textile Limited | Karachi Sindh, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Immersus Health Company, LLC | Milford, OH, United States | Specification developer | 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 | |
| J. Lynch Co., Ltd. | Kaohsiung, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jac Custom Pouches | Dowagiac, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JHQ New Material Technology Co., Ltd. | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hanfang Textile Technology Co., Ltd | Xuzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Keling Medical Appliances Co.,ltd. | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang City Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Saikang Medical Equipment Co., Ltd | Zhangjiagang Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd | Zhangjiagang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Unixcare Medical Devices Co.,ltd | Jiangyin Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiaxing Weimei Textile Co., Ltd | Jiaxing City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiehong Medical Products(bangladesh) Co.ltd | Chattogram Chittagong(Division), Bangladesh | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingxin Group (M) Sdn Bhd | Kulai Johor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingxin Group (M) Sdn Bhd | Kulai Johor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Yueer Art Craft Co.,ltd | Jinhua Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Huashi Medical Equipment Co.,Ltd | Jiangyin City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Ivy Home Textile Co. Limited. | Jinhua City Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joerns Healthcare | Charlotte, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joerns Healthcare | Arlington, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joerns Healthcare Brownsville | Brownsville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K2 Health Products | Brooklyn, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kap Medical | Corona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kentron Health Care, Inc. | Springfield, TN, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Khing Good Company | DONG GUAN Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimlead Hygiene Products (hebei) Co.,ltd. | Xingtai Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kreg Medical, Inc. | Melrose Park, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kuangzan (Zhejiang) Home Co., Ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linjiang (holdings) Limited | Shangqiu Henan, China | Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LKL Advance Metaltech Sdn Bhd | Seri Kembangan Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lucky Textile Mills Limited | KARACHI Sindh, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi | Izmir, Turkey | 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 | |
| Medtecs (cambodia) Corp. Limited | Srok Kampong Siem Kampong Cham, Cambodia | Contract manufacturer, Foreign private label distributor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mes | Seguin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mip Usa | Bolingbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mip, Inc. | ANJOU Quebec, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moxi Enterprises, LLC | Greenville, SC, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtrica Solutions Ltd | Surrey British Columbia, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mildy International Branch Company | Can Tho City, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Jiaqi Apparel 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 | |
| North America Mattress Corp. | Clackamas, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pearl Technology AG | Schlieren Zurich, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philipcare Medical Manufacturing Inc. | Lipa Batangas, Philippines | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poliuretanos, S.A. De C.V. | Toluca Mexico, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pottymd, LLC | Knoxville, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protect-A-Bed Korea Co., Ltd. | Seongnam Gyeonggi, South Korea | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protection Products, Inc. | Hickory, NC, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Picard Healthcare Technology (Dongguan) Co. Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quanzhou Apex Hygiene Products Co.,ltd | Jinjiang Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radscan Medical Equipment, Inc. | Phoenix, AZ, 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 | |
| Rogers Foam Corporation | Mt Sterling, KY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ROHO, Inc. | Belleville, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ronexmed S.A.S. | Barranquilla Atlantico, Colombia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rugao Smiling Healthcare Teconolgy Developent Co., Ltd | Rugao Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rogers Foam Tijuana S. de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secure Personal Care Products, LLC | South San Francisco, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Aishule Hygiene Products Co., Ltd | Linyi Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai No. 2 Medical College Duhang Medical Equipment Factory | Shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Shenbao Mattress Factory | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Yueyueshu Women Products Co.,ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang Liaoning, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Span-America Medical Systems, Inc. | Greenville, SC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Standard Textile Co., Inc. | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Medical | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun May Industrial Co., Ltd. | Pan Chiao City Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surface Medical, Inc. | Calgary Alberta, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Baili Medical Supplies Co.,ltd | Suzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Lantise Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan AST Medical Equipment Co., Ltd | Luzhou City Sichuan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sloan Medical | Omaha, NE, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Small Beginnings Inc. | Hesperia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tamarack Habilitation Technologies, Inc. | Blaine, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taylor Healthcare Products, Inc | Spring, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Pettibon System | Chehalis, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trinity Furniture Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Specification developer | 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 | |
| Vidales Larranaga SA de CV | Ahuachapan, El Salvador | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WCW,Inc | Manchester Center, VT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weifang Keepbetter Healthcare Co., Ltd. | Weifang Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welkong Sports Industrial Co.,ltd | Dongguan city Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Youfu International Trade Co.,ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhu Qicheng New Material Co.,ltd. | Wuhu Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuyi Kinda Industry & Trade Co., Ltd | JINHUA Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Walt Technology Group Co., Ltd. | Haining Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Walt USA, LLC | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weihai Hongyu Nonwoven Fabric Products Co.,Ltd | Weihai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xian Tao Crosscare Protective Products Co.,ltd | Xian Tao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yong Yi Viet Nam Co.,ltd | Duc Hoa Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Carenovo Technology Co., Ltd. | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Shininglion Technology Co.,ltd | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Tianyue Import And Export Co., Ltd. | Haining Zhejiang, China | 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 | |
| Zhejiang Longterm Medical Technology Co., LTD | Huzhou City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 2016. 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.