Data / Medical devices / Device, Fixation, Tracheal Tube
Device, Fixation, Tracheal Tube (CBH): 121 FDA-registered makers in 16 countries
121 establishments in 16 countries are registered with the FDA to make Device, Fixation, Tracheal Tube (product code CBH, Class 1, 21 CFR 868.5770). 4 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on September 24, 2014, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CBH
- Device class
- 1
- Regulation
- 868.5770
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| China | 42 |
| United States | 41 |
| Mexico | 10 |
| Pakistan | 5 |
| Germany | 4 |
| Taiwan | 4 |
| United Kingdom | 3 |
| India | 2 |
| Guatemala | 2 |
| Malaysia | 2 |
| Sweden | 1 |
| Chile | 1 |
| Spain | 1 |
| Israel | 1 |
| Dominican Republic | 1 |
| Turkey | 1 |
Makers of Device, Fixation, Tracheal Tube
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 |
|---|---|---|---|---|---|---|---|---|
| B & B Medical Technologies, Inc. | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 3 | December 2, 1993 | 0 | 0 | 0 | api.fda.gov |
| Coopersurgical, Inc. | Trumbull, CT, United States | Manufacturer, Repackager or relabeler | 1 | July 21, 1987 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Specification developer | 1 | December 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs de Mexico de S.A. de C.V. | Chihuahua Mexico, Mexico | Manufacturer | 1 | December 17, 1990 | 0 | 0 | 0 | api.fda.gov |
| Acheron Instruments (pvt.) Ltd. | LAHORE Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical Products Co., Ltd. | Zhijiang City Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allmed Medical Products Co., Ltd. | ZHIJIANG CITY Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atos Medical AB | HORBY Skane, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beyond Industries (nanjing) Limited | Nanjing Jiangsu, China | Contract manufacturer, 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 | |
| Bird & Cronin, LLC | Eagan, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brightwake Ltd | Kirkby-in-Ashfield Nottinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clip-Fab R&D Medical Instruments, S.L. | Barcelona Catalonia, Spain | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Haverhill, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dale Medical Products, Inc. | New London, CT, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Davol Surgical Innovations | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dimeda Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Shin Yi Healthcare Products Factory | DONG GUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Vincent Rehab Devices Company Limited | DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Benson Hood Laboratories, Inc. | Pembroke, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eon Meditech Pvt. Ltd. | Surat Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ergomed, Inc. | San Antonio, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Manufacturer, 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 | |
| Foxxmed Ltd | Ilan Yilan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Respiratory Solutions, Inc. (dba) Respiralogics | Reno, NV, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goldstar Medical Instruments | SIALKOT Punjab, Pakistan | 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 | |
| Gulmag International | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Garana Industries Private Limited | SIALKOT Punjab, Pakistan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract 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 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 | |
| Hitec Medical Co., Ltd | Shanghai, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Hollister Incorporated | Stuarts Draft, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hony Medical Co., Ltd | Taishan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei V-Medical Products Co., Ltd. | Xiantao Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Contract manufacturer, 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 | |
| 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 | |
| ICU Medical, Inc. | Dublin, OH, United States | 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 | |
| Innovatif Cekal Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovel Ltd | London London, City of, United Kingdom | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | YANGZHOU CITY, Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ostup Medical Products Co. Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen City Hubei, China | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kelcor, LLC | Chattanooga, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laerdal Medical (suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marpac, Inc. | Albuquerque, NM, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mcreat ( Guangzhou ) Bio-Tech Co.,ltd | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mes | Seguin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MME Willow Lake | Vadnais Hts, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount Blonck Trading | SIALKOT Punjab, Pakistan | 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 | |
| Neotech Products, LLC | Valencia, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Huakun Medical Equipment Co.,ltd | Cixi Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novem Medical S. De R.L. De C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeVap Inc Inventory Management | San Jose, CA, United States | Specification developer | 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 | |
| Ortho and Surgical Products Enterprises S.A. | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pepper Medical, Inc. | West Chester, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pergo Medikal Ve Ilac Sanayi Anonim Sirketi | Izmir, Turkey | 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 | |
| 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Posey, S. de R.L. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu City Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao Leckie Foam Products Co. Ltd. | Qingdao Shandong, 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 | |
| Securisyn Medical, LLC | Littleton, CO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Jinlai Huanhai Medical Technology Co.,ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Haitech Medical Products Co., Ltd | SHAOXING Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skil-Care Corp. | New Rochelle, NY, United States | Contract manufacturer, Manufacturer | 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 | |
| SUNSET HEALTHCARE SOLUTIONS, Inc. | Chicago, IL, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Konlida Medical Supplies Co., Ltd. | Suzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 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 | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunset Healthcare Solutions Central Warehouse | Elgin, IL, United States | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgicure Technologies, Inc. | Cambridge, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tacmed Solutions, LLC | Anderson, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taicang Yigao Medical Technology Co.,ltd | Taicang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tracoe Medical GMBH | NIEDER-OLM Rhineland-Palatinate, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri-Anim Health Services, Inc. | Dublin, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trident Manufacturing, Inc. | Pingree Grove, IL, United States | Contract 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 | |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VBM Medizintechnik GMBH | SULZ AM NECKAR Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcro (china) Fastening Systems Company Limited | ZHANGJIAGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcromex, S.A. De C.V. | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VR Medical Technology Co., Ltd. | KUNSHAN Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Warriornp LLC | Bloomfield Hills, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xenco Medical LLC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao Rayxin Medical Products Co., Ltd. | XIANTAO Hubei, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yafho Bio-Technology Co., Ltd. | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Haoding Medical Co.,ltd | Yiwu Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | YIWU Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zibo Qichuang Medical Products Co.,ltd. | Zibo Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 24, 2014. 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.