Data / Medical devices / Tubing, Pressure And Accessories
Tubing, Pressure And Accessories (BYX): 173 FDA-registered makers in 24 countries
173 establishments in 24 countries are registered with the FDA to make Tubing, Pressure And Accessories (product code BYX, Class 1, 21 CFR 868.5860). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 62 510(k) clearances under this code, the latest on June 13, 2001, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- BYX
- Device class
- 1
- Regulation
- 868.5860
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 62 |
| China | 45 |
| Taiwan | 11 |
| Mexico | 11 |
| Canada | 7 |
| United Kingdom | 6 |
| Switzerland | 4 |
| India | 4 |
| Germany | 3 |
| Malaysia | 3 |
| Pakistan | 2 |
| Turkey | 2 |
| Singapore | 2 |
| Dominican Republic | 1 |
| Finland | 1 |
| New Zealand | 1 |
| Sri Lanka | 1 |
| Thailand | 1 |
| Brazil | 1 |
| France | 1 |
| Indonesia | 1 |
| Australia | 1 |
| Lithuania | 1 |
| Vietnam | 1 |
Makers of Tubing, Pressure And Accessories
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 |
|---|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | January 12, 1994 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 1 | January 12, 1994 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer, Repackager or relabeler | 1 | January 12, 1994 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 1 | September 11, 1978 | 0 | 0 | 0 | api.fda.gov |
| A & I Industries Ltd | FOSHAN CITY Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accutron, Inc. | Phoenix, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AG Industries LLC | Fairburn, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Air Techniques, Inc. | Melville, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alljack Technologies, Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMBU Limited | XIANG YU F.T.Z., XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amis (xiamen) Cultural Creativity Co., Ltd | Xiamen Fujian, China | 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 | |
| Amt Medical Inc. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angioadvancements, LLC | N Ft Myers, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Medsource Group Limited | Hongkong, China | Contract manufacturer, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amico Patient Care Corporation | Richmond Hill Ontario, Canada | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Trenton | TRENTON Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bay Corporation | Westlake, OH, United States | Contract manufacturer, 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 | |
| Bonree Medical Co., Ltd | Zhongshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | 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 | |
| Cardinal Health 200, LLC | Jacksonville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health P.R. 218, Inc. | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Choice One Medical Inc | Windsor Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Custom Assemblies, Inc. | Pine Level, NC, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 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 | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D R Burton Healthcare, LLC | Farmville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang Airtech Co.,ltd | danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danyang Xinya Valve Co., Ltd. | Danyang Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DEHAS Medical Systems GmbH | Luebeck Schleswig-Holstein, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRW Medical | Aston, PA, 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 | |
| Economec Electro-Medical Equipment Inc. | BOISBRIAND Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endoclot Plus Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endure Industries, Inc. | Homer, NY, United States | Specification developer | 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 | |
| Fisher & Paykel Healthcare, Ltd. | EAST TAMAKI Auckland, New Zealand | Complaint file establishment, Manufacturer, Repackager or relabeler | 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 | |
| Flotec, Inc. | Eagle Creek, IN, United States | Complaint file establishment, Manufacturer | 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, 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 | |
| Gentec (shanghai) Corporation | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Groman Inc. | Coconut Creek, FL, United States | 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 | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gloor Ltd. | Burgdorf Bern, Switzerland | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Schauenburg-Truplast Hose Technology Ltd. | Guangzhou Guangdong, China | Contract manufacturer | 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 | |
| Hamilton Medical AG | BONADUZ Graubunden, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Medical, Inc. | Reno, NV, United States | Contract 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 | |
| Hexamed Pvt Ltd | Sialkot Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hilbro International (pvt) Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoyt Medical LLC | Gold Canyon, AZ, United States | 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 | |
| Huzhou Junda Industry Co., Ltd. | Anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Medical AG | Domat / Ems Graubunden, Switzerland | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hamilton Medical AG | Domat/Ems Graubunden, Switzerland | Complaint file establishment, 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 | |
| Instrumentation Industries, Incorporated | Bethel Park, PA, United States | Manufacturer, Repackager or relabeler | 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 | |
| Ipax, Inc. | Englewood, CO, United States | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Summit Co., Ltd. | Chomthong Krung Thep Maha Nakhon, Thailand | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Power Electromechanical Technology 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 | |
| Javid de Mexico S. De R.L. De C.V. (resplabs) | Nogales Sonora, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koo (Shanghai) Industries Co., Ltd | Songjiang Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lamed Private Limited | FARIDABAD Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liviliti Health Products Corp | Sarasota, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer | 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 | |
| Magnamed Tecnologia Medica S/A | Sao Paulo, Brazil | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet (suzhou) Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet S.A.S. | ARDON, ORLEANS CEDEX 2 Loiret, France | Contract 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 | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MPS Project | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mallinckrodt Manufacturing LLC | Madison, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| McARTHUR MEDICAL SALES, INC. | Rockton, Ontario, Canada | Specification developer | 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 | |
| Meditera Tibbi Malzeme Sanayi ve Ticaret A.S. | Tire Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus CMF | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Kohden Orangemed, LLC | Santa Ana, CA, United States | Specification developer | 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 | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Runmai Medical Technology Co., Ltd. | Cixi Zhejiang, China | Manufacturer, Repackager or relabeler | 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 HSCC Medical Technology Co., Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norres Baggerman US, LLC | Abbeville, SC, United States | Contract 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 | |
| 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ohio Medical LLC | Gurnee, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pari Respiratory Equipment, Inc. | Midlothian, VA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plaxtron Industrial (M) Sdn. Bhd. | IPOH Perak, Malaysia | Contract 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 | |
| Precision Medical, Inc. | Northampton, PA, United States | 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 | |
| Purple Surgical International Limited | Herts England, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Purple Surgical Manufacturing Limited | Taunton Somerset, United Kingdom | Contract 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 | |
| Reel Free Corporation | Rockford, MI, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reprocessing Products Corporation (RPC) | Tucson, AZ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 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 Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rmo | Johor Bahru, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Romax Hose, Inc. | Laceyville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Romsons International | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Asia Pte. Ltd. | Singapore South West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed Corp | Lithia Spgs, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ResMed West Coast Warehouse | Moreno Valley, CA, United States | Contract 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 | |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing Zhejiang, 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 Sany Pioneer Technology 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 | |
| Soleetech Corporation | Lujhou Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Somnetics International, Inc | Fridley, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunmed Ap, Ltd. | ZHUHAI Guangdong, China | Contract 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 | |
| Salter Labs | El Paso, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Wellcore Well Technology CO., LTD | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterling Medical Products | Prophetstown, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Superior Products, LLC | Brooklyn, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnologias Medicas Innovadoras S De RL | H. MATAMOROS Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Cardiovascular Systems Corporation | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Truer Medical, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| UAB Intersurgical | PABRADE Svencionys, 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 | |
| Venner Medical (singapore) Pte Ltd | Singapore Central Singapore, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vietnam Medical Plastic JSC | Tam Diep Ward Ninh Binh, Vietnam | Contract manufacturer, Contract sterilizer | 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 | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Worldcross Industries Co., Ltd. | DONG YANG Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Western Enterprises, Inc. | Westlake, OH, United States | 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhong Meidi Medical Products Co., Ltd. | Yangzhong City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Guanghua Medical Hose Technology Co., Ltd. | Jiaxing City Zhejiang, China | Exporter to the US, 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 | |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Contract 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.