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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

CountryMakers
China42
United States41
Mexico10
Pakistan5
Germany4
Taiwan4
United Kingdom3
India2
Guatemala2
Malaysia2
Sweden1
Chile1
Spain1
Israel1
Dominican Republic1
Turkey1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
B & B Medical Technologies, Inc.Carlsbad, CA, United StatesComplaint file establishment, Specification developer3December 2, 1993000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer, Repackager or relabeler1July 21, 1987000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer1December 17, 1990000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoManufacturer1December 17, 1990000api.fda.gov
Acheron Instruments (pvt.) Ltd.LAHORE Punjab, PakistanManufacturer0000api.fda.gov
Allmed Medical Products Co., Ltd.Zhijiang City Hubei, ChinaManufacturer0000api.fda.gov
Allmed Medical Products Co., Ltd.ZHIJIANG CITY Hubei, ChinaManufacturer0000api.fda.gov
Atos Medical ABHORBY Skane, SwedenManufacturer0000api.fda.gov
Beyond Industries (nanjing) LimitedNanjing Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Bird & Cronin, LLCEagan, MN, United StatesManufacturer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Brightwake LtdKirkby-in-Ashfield Nottinghamshire, United KingdomManufacturer0000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer0000api.fda.gov
Carwild Corp.New London, CT, United StatesContract manufacturer0000api.fda.gov
Clip-Fab R&D Medical Instruments, S.L.Barcelona Catalonia, SpainContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
CM Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Cordica Medical, Inc.Haverhill, MA, United StatesContract manufacturer0000api.fda.gov
Create Biotech Co., Ltd.Taoyuan City, TaiwanManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Dale Medical Products, Inc.New London, CT, United StatesManufacturer0020api.fda.gov
Davol Surgical InnovationsCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Dongguan Shin Yi Healthcare Products FactoryDONG GUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Dongguan Vincent Rehab Devices Company LimitedDONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Dongguan Hong De Medical Plastic Products Co. Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
E. Benson Hood Laboratories, Inc.Pembroke, MA, United StatesManufacturer0000api.fda.gov
Eon Meditech Pvt. Ltd.Surat Gujarat, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Ergomed, Inc.San Antonio, TX, United StatesSpecification developer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelManufacturer, Specification developer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer0000api.fda.gov
Foxxmed LtdIlan Yilan, TaiwanContract manufacturer0000api.fda.gov
Global Respiratory Solutions, Inc. (dba) RespiralogicsReno, NV, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Goldstar Medical InstrumentsSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Guangzhou Amk Medical Equipment Co.,ltd.Guang zhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gulmag InternationalSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Garana Industries Private LimitedSIALKOT Punjab, PakistanContract manufacturer, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hangzhou Alline Plastic Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hangzhou Formed Medical Devices Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Shanyou Medical Equipment Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hitec Medical Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hollister IncorporatedLibertyville, IL, United StatesSpecification developer0010api.fda.gov
Hollister IncorporatedStuarts Draft, VA, United StatesManufacturer0000api.fda.gov
Hony Medical Co., LtdTaishan Guangdong, ChinaManufacturer0000api.fda.gov
Hubei V-Medical Products Co., Ltd.Xiantao Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Huizhou Foryou Medical Devices Co.,ltd.HuiZhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer0000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Innovatif Cekal Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Innovel LtdLondon London, City of, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.YANGZHOU CITY, Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Ostup Medical Products Co. Ltd.Nanjing Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.Jingmen City Hubei, ChinaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Kelcor, LLCChattanooga, TN, United StatesSpecification developer0000api.fda.gov
Laerdal Medical (suzhou) Co., Ltd.215009 Suzhou Jiangsu Province, ChinaManufacturer0000api.fda.gov
Marpac, Inc.Albuquerque, NM, United StatesManufacturer0000api.fda.gov
Mcreat ( Guangzhou ) Bio-Tech Co.,ltdGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0010api.fda.gov
Medsorb Dominicana, S.A.San Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
MesSeguin, TX, United StatesSpecification developer0000api.fda.gov
MME Willow LakeVadnais Hts, MN, United StatesContract manufacturer0000api.fda.gov
Mount Blonck TradingSIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Medease Life Co.,LtdDANYANG Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Neotech Products, LLCValencia, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Ningbo Huakun Medical Equipment Co.,ltdCixi Zhejiang, ChinaManufacturer0000api.fda.gov
Novem Medical S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
NeVap Inc Inventory ManagementSan Jose, CA, United StatesSpecification developer0000api.fda.gov
Ningbo Great Mountain Medical Instruments Co.,LtdNingbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Pepper Medical, Inc.West Chester, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Pergo Medikal Ve Ilac Sanayi Anonim SirketiIzmir, TurkeyManufacturer0000api.fda.gov
Plastics Plus Technology, Inc.Redlands, CA, United StatesContract manufacturer0000api.fda.gov
Precision Medical, Inc.Northampton, PA, United StatesManufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoManufacturer0000api.fda.gov
Posey, S. de R.L. de C.V.Tijuana Baja California, MexicoManufacturer0000api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.Pinghu City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Qingdao Leckie Foam Products Co. Ltd.Qingdao Shandong, ChinaManufacturer0000api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.Nuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Securisyn Medical, LLCLittleton, CO, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Shandong Jinlai Huanhai Medical Technology Co.,ltdYantai Shandong, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shaoxing Haitech Medical Products Co., LtdSHAOXING Zhejiang, ChinaManufacturer0000api.fda.gov
Skil-Care Corp.New Rochelle, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Sun May Industrial Co., Ltd.Pan Chiao City Taipei, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
SUNSET HEALTHCARE SOLUTIONS, Inc.Chicago, IL, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Suzhou Konlida Medical Supplies Co., Ltd.Suzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Sichuan AST Medical Equipment Co., LtdLuzhou City Sichuan, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Sunset Healthcare Solutions Central WarehouseElgin, IL, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler0000api.fda.gov
Surgicure Technologies, Inc.Cambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tacmed Solutions, LLCAnderson, SC, United StatesSpecification developer0000api.fda.gov
Taicang Yigao Medical Technology Co.,ltdTaicang Jiangsu, ChinaManufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesSpecification developer0000api.fda.gov
Tracoe Medical GMBHNIEDER-OLM Rhineland-Palatinate, GermanySpecification developer0000api.fda.gov
Tri-Anim Health Services, Inc.Dublin, OH, United StatesSpecification developer0000api.fda.gov
Trident Manufacturing, Inc.Pingree Grove, IL, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Teleflex Medical Sdn. Bhd.KAMUNTING Perak, MalaysiaManufacturer, Specification developer0000api.fda.gov
VBM Medizintechnik GMBHSULZ AM NECKAR Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Velcro (china) Fastening Systems Company LimitedZHANGJIAGANG Jiangsu, ChinaContract manufacturer0000api.fda.gov
Velcromex, S.A. De C.V.AGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
VR Medical Technology Co., Ltd.KUNSHAN Jiangsu, ChinaContract manufacturer0000api.fda.gov
Warriornp LLCBloomfield Hills, MI, United StatesSpecification developer0000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Xiantao Rayxin Medical Products Co., Ltd.XIANTAO Hubei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yafho Bio-Technology Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Yiwu Haoding Medical Co.,ltdYiwu Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Hongyu Medical Commodity Co., Ltd.YIWU Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.Zibo Shandong, ChinaExporter to the US, Manufacturer0000api.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.