Data / Medical devices / Cannula, Nasal, Oxygen
Cannula, Nasal, Oxygen (CAT): 196 FDA-registered makers in 22 countries
196 establishments in 22 countries are registered with the FDA to make Cannula, Nasal, Oxygen (product code CAT, Class 1, 21 CFR 868.5340). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on June 13, 2001, and lists 2 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
- CAT
- Device class
- 1
- Regulation
- 868.5340
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| China | 84 |
| United States | 34 |
| Mexico | 16 |
| Taiwan | 16 |
| India | 7 |
| United Kingdom | 6 |
| Germany | 6 |
| Pakistan | 5 |
| Canada | 4 |
| Malaysia | 4 |
| Australia | 2 |
| Lithuania | 2 |
| Japan | 1 |
| New Zealand | 1 |
| Sri Lanka | 1 |
| South Korea | 1 |
| Iceland | 1 |
| Turkey | 1 |
| Indonesia | 1 |
| Colombia | 1 |
| France | 1 |
| Costa Rica | 1 |
Makers of Cannula, Nasal, Oxygen
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 |
|---|---|---|---|---|---|---|---|---|
| Salter Labs | El Paso, TX, United States | Specification developer | 3 | October 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | October 18, 1991 | 0 | 0 | 0 | api.fda.gov |
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AG Industries LLC | Fairburn, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airway Innovations, Inc. | Buffalo Grove, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| All Quality & Services, Inc. | Garland, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | 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 Spenq Industrial Co., Ltd. | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armstrong Medical Ltd. | COLERAINE Northern Ireland, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atom Medical Corporation | Sakura-ku, Saitama-shi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | 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 | |
| Beijing Rongrui Century Science Technology Co.,ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Winsunny Harmony Science&technology Co., Ltd. | Bei jing Beijing, China | Manufacturer | 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 | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bonree Medical Co., Ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BPR Medical Limited | Mansfield Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braebon Medical Corp. | KANATA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baja Fur S.A. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Manchester, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Besmed Health Business Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cnsac Medshop GMBH | Theilheim Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | MISSISSAUGA Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang Xinya Valve Co., Ltd. | Danyang Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Rongrui-Century Science&technology Co., Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Doner Industries, Inc. | Rogers, AR, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Interservices GmbH | Luebeck Schleswig-Holstein, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draegerwerk AG & Co. KGaA | LUEBECK Schleswig-Holstein, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynasthetics | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enter Medical Corporation | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evereast Medical Products Group Co., Ltd | Changyuan City Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excellentcare Medical (Huizhou) Ltd. | Huizhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fesun Shanghai Co., Ltd. | shanghai, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare S.a.de C.V. | Tijuana, Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer | 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 | |
| Foremount Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Medical Instrument Corp. | Taoyuan City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foxxmed Ltd | Ilan Yilan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fisher & Paykel Healthcare S.A.de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Lanka (Pvt) Ltd | Bandaragama Western, Sri Lanka | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galemed Corp. | WU-JIA Yilan, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garish Apparels | Wazirabad Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd. (wuxi) | Wuxi Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gcmedica Enterprise Ltd.(wuxi) | WUXI Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gentec (shanghai) Corporation | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Group Medical Co Ltd. | Changhua County, Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guang Dong Eda Technology Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Ecan Medical Co,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Amk Medical Equipment Co.,ltd. | Guang zhou Guangdong, China | Contract manufacturer, 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 | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hainan Madewell Medical Technology Co.,ltd. | Danzhou Hainan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haiyan Kangyuan Medical Instrument Co.,ltd. | JiaXing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Formed Medical Devices Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Shanyou Medical Equipment Co.,ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Superds Industry Co., Ltd. | Hangzhou City Zhejiang, China | 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 | |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Headstar Medical Products Co., Ltd | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Aile Industrial Co., Ltd. | zhengzhou Henan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospitech Manufacturing Services Sdn Bhd | Shah Alam Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hsiner Co., Ltd. | Taichung City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hue Light Co., Ltd | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou City Zhejiang, China | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harsoria Healthcare Pvt. Ltd. (Unit-2) | Baddi Himachal Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang Hebei, China | 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 | |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Plasticas Medicas, S.A. De C.V. | Ayala Morelos, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Ltd. | Wokingham, Berkshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Apparatus (changzhou) Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invent Medical Corporation | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventeur, LLC | Saint Petersburg, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Icon Plastics Pty Ltd | Hallam Victoria, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrial Vallera de Mexicali, S. A. de C. V. | Mexicali Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical Medical Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract 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 Mcare Medical Co.,ltd. | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Yiles Medical Co., Ltd | Nanchang City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K-Med Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo (Shanghai) Industries Co., Ltd | Songjiang Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Corporation | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Loewenstein Medical Americas Corp. | Alpharetta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mada Medical Products, Inc. | Carlstadt, NJ, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Madewell Medical Technology (malaysia) Sdn., Bhd. | Kuala Ketil Kedah, Malaysia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medin Medical Innovations GMBH | Olching Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meditech Systems Limited | Shaftesbury Dorset, United Kingdom | 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 | |
| Masimo Medical Technologies (Malaysia) SDN BHD | Pasir Gudang Johor, Malaysia | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medease Life Co.,Ltd | DANYANG Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nantong Kangjinchen Medical Equipment Co., Ltd. | Nantong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neurovirtual Usa, Inc. | Fort Lauderdale, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Besmed Medical Equipment Corp. | NINGBO Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Castle Medical Import & Export Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer, 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 | |
| Ningbo Hanyue Medical Technology Co.,ltd | CIXI CITY Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Mflab Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Runmai Medical Technology Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Shengyurui Medical Appliance Co. | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yingmed Medical Instruments Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Non-Change Enterprise Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nox Medical | Reykjavik, Iceland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices Mexico LLC | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Great Mountain Medical Instruments Co.,Ltd | Ningbo Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O-Two Medical Technologies, Inc. | Brampton Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omnimate Enterprise Co., Ltd. | Ilan County Yilan, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orantech Inc. | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plastics Plus Technology, Inc. | Redlands, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poeppelmann GMBH Co KG Kunststoffwerk Werkzeugbau | Lohne Lower Saxony, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poly Medicure Ltd. | Faridabad Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymed (xiamen) Plastic Industrial Co.,ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Indonesia Fullcare Medical | Batang Jawa Tengah, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qinhuangdao Kapunuomaite Medical Equipment S&T Co., Ltd. | Qinhuangdao Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rci Hudson De Mexico S. De RL. De CV. | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resmed Pty Ltd. | BELLA VISTA New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Romsons International | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ronexmed S.A.S. | Barranquilla Atlantico, Colombia | Manufacturer | 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 | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Jiancheng Medical Products Co., Ltd. | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Coreray Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Harveymed Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen city Guangdong, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Homed Medical Device Co Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Med-Link Electronics Tech Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Yimi Care Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Ltd. | Devens, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SMC Medical Manufacturing Private Limited | BANGALORE Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Southmedic, Inc. | BARRIE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunder Biomedical Tech. Co., Ltd. | Yunlin County, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suru International Pvt Ltd | DAHANU Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Exporter to the US, 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 | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunset Healthcare Solutions Central Warehouse | Elgin, IL, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Technimen Skillers | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | 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 | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Telesair, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trelleborg Sealing Solutions US, Inc | Delano, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | Visaginas Salcininkai, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VADI Medical Technology Co., Ltd. | Taoyuan City, Taiwan | 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 | |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vapotherm Inc. | Exeter, NH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation by Volcarica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WESTMED de Mexico, S.A de C.V. | Tecate Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WHR Hossinger Kunststofftechnik GMBH | Roding Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed Javid de Mexico, S.A. de C.V. | NOGALES Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westmed de Mexico, S.A de C.V | NOGALES Sonora, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yadu Medical (henan) Co., Ltd | Changyuan Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yuyao Jiahua Medical Appliance, Co., Ltd. | Yuyao Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou City Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing 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 Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Sungood Technology Co.,ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Hongze Medical Technology Co., Ltd. | Zhongshan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Medtec Medical devices Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 13, 2001. 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.