Data / Medical devices / Stand, Infusion
Stand, Infusion (FOX): 224 FDA-registered makers in 26 countries
224 establishments in 26 countries are registered with the FDA to make Stand, Infusion (product code FOX, Class 1, 21 CFR 880.6990). 0 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on April 6, 1998, and lists 5 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
- FOX
- Device class
- 1
- Regulation
- 880.6990
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 85 |
| China | 67 |
| Taiwan | 13 |
| Canada | 12 |
| India | 8 |
| Germany | 6 |
| Mexico | 4 |
| Singapore | 3 |
| Netherlands | 3 |
| New Zealand | 2 |
| Switzerland | 2 |
| United Kingdom | 2 |
| Colombia | 2 |
| France | 2 |
| Vietnam | 2 |
| Belize | 1 |
| Cambodia | 1 |
| Sweden | 1 |
| Dominican Republic | 1 |
| Australia | 1 |
| Slovakia | 1 |
| Israel | 1 |
| South Korea | 1 |
| Japan | 1 |
| Indonesia | 1 |
| Malaysia | 1 |
Makers of Stand, Infusion
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 |
|---|---|---|---|---|---|---|---|---|
| A & I Industries Ltd | FOSHAN CITY Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accord Precision Limited | Manukau Auckland, New Zealand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Algonquin Industries Inc | Bellingham, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMTRION GMBH (formerly Haseke & Kroemker) | Porta Westfalica North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Health Care MFG., Inc. | Min Hsiung Shiang Chiayi(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashoka Company Limited | Belize City, Belize | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | 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 | |
| Axora Medical, Inc. | Sunnyvale, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aikin Healthcare Co., LTD | Kunshan Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BD Switzerland Sarl | Eysins Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Rochester, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Better Medical Technology Co., Ltd. | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bliss (cambodia) Health Product Co., Ltd. | Basedth District Kampong Speu, Cambodia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bliss Health Products Co., Ltd. | Zhongshan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breas Medical AB | MOLNLYCKE Vastra Gotaland, Sweden | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bimini Health Tech | Plano, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blickman Industries LLC | Lawrenceburg, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | Jacksonville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caremax Rehabilitation Equipment Co., Ltd. | Foshan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cim Med GMBH | Munich Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coriton Instrument Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTC Holdings Inc. | Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Care&Care Health Products Co., Ltd | Yuanli Township Miaoli, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinton Industries, Inc | York, PA, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Com-Bridge International Co., Ltd. | Gangkou Town, Zhongshan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConMed Corporation | Greenwood Village, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang Maxthai Medical Equipment Co., Ltd. | Danyang City, Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang New Hope Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deltex Medical Limited | CHICHESTER West Sussex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Double Care Medical Technology Co.,ltd. | Liwu Shiwan Boluo Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Double Care Medical Technology Co.,ltd. | Huizhou City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynafocus Industry Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dragon Medical Co.,Ltd | Suzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dymax, Corp. | Zelienople, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno Australia | Brendale Queensland, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno-Washington, Inc. | Wilmington, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Firefly Medical, Inc. | Fort Collins, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fort Metal Plastic Products (huizhou) Co., Ltd | Guongdong Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Any Home Care Medical Technology Co.,ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Dongfang Medical Equipment Manufactory(ltd) | FOSHAN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Huafukang Medical Technology Co. Ltd | Foshan City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Nanhai Hongchen Medical Equipments Co.,ltd | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Rafu Medical Technology Co., Ltd | Foshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Shenyu Medical Equipment Co., Ltd. | Foshan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Shunkangda Medical Tech Co.,ltd | FOSHAN CITY Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Suncare Medical Products Co Ltd | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frantz Medical Development, Ltd. | Mentor, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno Slovakia s.r.o. | Slovak Republic Trenciansky, Slovakia | Complaint file establishment, Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Fuzikon Medical Technology Co.Ltd | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GCX Corporation | Petaluma, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GCX Corporation | El Paso, TX, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genemax Medical Products Industry Corp. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gentry Hardware Products Co. Ltd. | Zhong Shan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Golden Season Pte Ltd | SINGAPORE North West, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Shunde LQX Health Technology Inc. | Foshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fuyang Hongwei Metal Product Limited Company | Hangzhou City Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Care Logistics, Inc. | Circleville, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Source Medical Equipment (guangdong) Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Healthplus Medical Device Co Ltd | Handan city Hebei, 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 Mlush Sanitary Products Co.,ltd | Hefei Anhui, China | 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 | |
| Hengshui Shuntai Kangyuan Medical Equipment Co.,ltd | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Metals Inc | Bellingham, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom De Mexico S De RL De CV | APODACA Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom, Inc. | Batesville, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Homecare Enterprise Co., Ltd. | Changhua City, Taiwan | 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 | |
| Hangzhou Dunli Medical Instruments Co.,Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Home Medical Products Inc. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icu Medical, Inc. | Lake Forest, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imperial Surgical Ltd. | Lachine Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indes Healthcare B.V. | Enschede Overijssel, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industria Colombiana De Dotaciones Metalicas-Dometal S.A.S | Medellin Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Metalicas Los Pinos SA | ITAGUI Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iradimed Corporation | Orlando, FL, United States | 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 | |
| J Sterling Industries LLC | Kalamazoo, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Sterling Industries Ltd. | Woodbridge Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J. Sterling Industries Ltd. | Concord Ontario, Canada | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Janman Precision Industry Co., Ltd. | Taoyuan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Assure Medical Equipment Co., Ltd | ZHENJIANG CITY Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd | Danyang Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Mcare Medical Co.,ltd. | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rixin Medical Equipment Co., Ltd | Zhangjiagang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Saikang Medical Equipment Co., Ltd | Zhangjiagang Jiangsu, China | 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 Newrise Medical Equipment Co.,ltd | JiangYin Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Singapore) Pte Ltd | Singapore Central Singapore, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jan Mao Industries Co., Ltd. | Guangxi Zhuang Autonomous Region, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Suntec Medical Technology Co., Ltd. | Jiepai Danyang Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jianlian Homecare Products CO., LTD. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifeport, LLC. | Woodland, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liebel-Flarsheim Company LLC | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LinkBio Corp. | Dover, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) | GANANOQUE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mac Medical | Millstadt, IL, United States | Contract manufacturer, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet (suzhou) Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medco MFG. | Spring, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Technology Industries, Inc. | Salt Lake City, UT, United States | 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 | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merits Healthcare Industries. (suzhou) Co., Ltd. | Jiangsu Province, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mid Central Medical | Saint Vincent, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minerva Surgical, Inc. | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mizuho Orthopedic Systems, Inc. | Union City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mobility Source Medical Technology Co., Ltd. | Foshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc | Hillsboro, OR, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MOTUS GI Medical Technologies Ltd. | Tirat Carmel Haifa, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medegen Medical Products | Gallaway, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracell Co.,Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo Inc. | Tualatin, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modo, Inc. | McMinnville, OR, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | 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 | |
| Nipro Canada Corporation | LINDSAY Ontario, Canada | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nxstage Medical, Inc. | Lawrence, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexxspan Healthcare LLC | Norcross, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Northgate Technologies Inc. | Elgin, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novadaq Technologies ULC | Burnaby British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novum Medical Products | Amherst, NY, United States | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oakworks, Inc. | New Freedom, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ondal Medical Systems GMBH | Huenfeld Hesse, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ondal Medical Systems Of America, Inc. | Sandston, VA, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PARAMOUNT BED CO., LTD. Chiba Factory | Sammu-shi Chiba, Japan | Complaint file establishment, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pedigo Products, Inc. | Vancouver, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Fluidics Division Parker Hannifin Corp. | Hatfield, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROVITA Medical GmbH & Co. KG | WERMELSKIRCHEN North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pryor Products | Oceanside, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT. Mega Andalan Kalasan | JOGYAKARTA Yogyakarta, Indonesia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paras Surgico Factory | Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn.Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Enmei Hai Leather Products Co.,ltd | QINGDAO Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quest Medical, Inc. | Allen, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiation Products Design, Inc. | Albertville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Raise Medical Industries, Inc. | Foshan City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Re:build Tekna, LLC | Kalamazoo, MI, United States | Contract 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 | |
| Recor Medical | Palo Alto, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rockford Specialties | Loves Park, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seca | Hamburg, Germany | 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 | |
| Shenyang Ourpromise Medical Equipment Co., Ltd. | Shenyang Liaoning, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sipa | Avesnes Sur Helpe Hauts-de-France, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smeed Technologies LLC | Cumming, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectros Medical Devices Inc | Houston, TX, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Steelcraft Incorporated | Pembina, ND, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stickman Dialysis Industries Inc. | Arundel, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Medical | Portage, MI, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Summit Medical LLC | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sharps Compliance, Inc. | Houston, TX, United States | Specification developer | 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 | |
| Skytron, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | Toronto Ontario, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Surgical GmbH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimount Medical Inc | Quebec, Canada | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TOUCHPOINT MEDICAL, Inc. | Odessa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trolli King (holding) Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TSC Life | Almelo Overijssel, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tswen Hoei Enterprise Vietnam Co., Ltd. | Ho Chi Minh City, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tuper Medical Co., Ltd. | Dezhou City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Brewer Company LLC | Menomonee Falls, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Surgical Company International B.V. | Amsterdam Noord-Holland, Netherlands | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Traverse Rescue LLC | Oakville Ontario, Canada | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Umano Medical Inc | L Islet Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Metal Fabricators, Inc. | Johnstown, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Poly Engineering Pvt. Ltd. | New Delhi, India | 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 | |
| Velocity Concept Development Group, LLC | Cambridge, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venture Corporation Limited | Singapore North East, Singapore | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verathon Medical (canada) ULC | Burnaby British Columbia, Canada | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verathon Medical (canada) ULC. | BURNABY British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wells Johnson Co. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WIPRO GE HEALTHCARE PRIVATE Ltd. | BANGALORE Karnataka, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wu Ho Medical Instruments MFG. Co. Ltd. | Taipei Hsien, Taiwan, (China), Taiwan | 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 | |
| Wipro GE Healthcare Private Ltd. | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Y.M.K. International Co., Ltd. | TAIPEI New Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Weideli Trading Co., Ltd. | Yangzhou Jiangsu, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yi Yi Transworld Corp. | Taichung City, Taiwan | Exporter to the US, 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 New Fellow Med 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 | |
| Zhenjiang Assure Medical Equipment Co Ltd | ZHENJIANG CITY Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhong Shan Lebo Medical Company Limited | Zhongshan City Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan A&e Machinery Industry Co., Ltd | Zhongshan City Guangdong, 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 | |
| ZJG Royaltrust Med Co., Ltd. | Zhangjiagang City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Bliss Medical Instrument Co., Ltd | Xiaolan, Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 6, 1998. 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.