Data / Medical devices / Bronchoscope (Flexible Or Rigid)
Bronchoscope (Flexible Or Rigid) (EOQ): 104 FDA-registered makers in 19 countries
104 establishments in 19 countries are registered with the FDA to make Bronchoscope (Flexible Or Rigid) (product code EOQ, Class 2, 21 CFR 874.4680). 61 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 244 510(k) clearances under this code, the latest on September 23, 2026, and lists 46 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- EOQ
- Device class
- 2
- Regulation
- 874.4680
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 33 |
| China | 17 |
| Japan | 11 |
| Germany | 10 |
| Mexico | 6 |
| Malaysia | 5 |
| Costa Rica | 4 |
| France | 3 |
| Canada | 2 |
| Israel | 2 |
| Taiwan | 2 |
| Czechia | 2 |
| Denmark | 1 |
| Ireland | 1 |
| Vietnam | 1 |
| United Kingdom | 1 |
| Nicaragua | 1 |
| Estonia | 1 |
| Pakistan | 1 |
Makers of Bronchoscope (Flexible Or Rigid)
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 |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 23 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 13 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 11 | April 23, 2026 | 0 | 2 | 0 | api.fda.gov |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Complaint file establishment, Manufacturer, Specification developer | 11 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 11 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Sunnyvale, CA, United States | Specification developer | 11 | September 23, 2025 | 0 | 5 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 11 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| AOMORI OLYMPUS CO., LTD. Kuroishi Site | KUROISHI-SHI Aomori, Japan | Manufacturer | 10 | June 4, 2025 | 0 | 1 | 0 | api.fda.gov |
| Ambu A/S | Ballerup Hovedstaden, Denmark | Specification developer | 9 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 9 | January 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 8 | October 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hunan Vathin Medical Instrument Co., Ltd. | Xiangtan Hunan, China | Exporter to the US, Manufacturer | 7 | July 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 6 | March 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Auris Health, Inc | Santa Clara, CA, United States | Manufacturer, Specification developer | 5 | July 25, 2026 | 0 | 4 | 0 | api.fda.gov |
| Auris Health, Inc. | San Jose, CA, United States | Manufacturer, Repackager or relabeler | 5 | July 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Broncus Medical Inc | San Jose, CA, United States | Manufacturer | 5 | May 31, 2024 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 5 | June 15, 2023 | 0 | 1 | 0 | api.fda.gov |
| Verathon Medical (canada) ULC | Burnaby British Columbia, Canada | Specification developer | 5 | May 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Verathon Medical (canada) ULC. | BURNABY British Columbia, Canada | Manufacturer | 5 | May 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, Inc. | Santa Clara, CA, United States | Manufacturer | 4 | September 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 4 | March 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Plymouth, MN, United States | Manufacturer, Specification developer | 3 | April 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Axess Vision Technology | Joue Les Tours Indre-et-Loire, France | Manufacturer | 2 | February 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 2 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 2 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 2 | November 22, 1994 | 0 | 1 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 2 | November 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, S. de R.L. de C.V. | Mexicali Baja California, Mexico | Exporter to the US, Manufacturer | 2 | April 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Intuitive Surgical, S. de R.L. de C.V. | Mexicali Baja California, Mexico | Exporter to the US, Manufacturer | 2 | April 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Macrolux Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Olympus Vietnam Co. Ltd. | Dong Nai City, Vietnam | Manufacturer | 2 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shanghai AnQing Medical Instrument Co., Ltd | Shanghai, China | Exporter to the US, Manufacturer | 2 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Anrei Medical (Hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Manufacturer | 1 | April 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Body Vision Medical Ltd | Netanya Tel Aviv, Israel | Manufacturer | 1 | April 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Body Vision Medical Lungvision Tool Manufacturing | Netanya Northern, Israel | Manufacturer | 1 | April 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Spencer, IN, United States | Manufacturer | 1 | March 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 1 | March 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| Contra Healthcare Solutions LLC | Butler, PA, United States | Manufacturer, Specification developer | 1 | April 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 1 | September 2, 2026 | 0 | 0 | 0 | api.fda.gov |
| Harada | Osaka, Japan | Specification developer | 1 | March 12, 1986 | 0 | 0 | 0 | api.fda.gov |
| Horizons Intl. Corp. | Heredia, Costa Rica | Contract manufacturer, Manufacturer, Repackager or relabeler | 1 | August 12, 2002 | 0 | 0 | 0 | api.fda.gov |
| Hunan Endoso Life Technology Co., Ltd | XiangTan Hunan, China | Manufacturer | 1 | February 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medimaging Integrated Solution Inc. | Hsinchu Hsinchu(City), Taiwan | Exporter to the US, Manufacturer | 1 | May 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Mercator Medsystems, Inc. | San Leandro, CA, United States | Manufacturer | 1 | July 2, 2013 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 1 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 1 | July 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| NOAH MEDICAL Corp. | San Jose, CA, United States | Manufacturer | 1 | March 1, 2023 | 0 | 5 | 0 | api.fda.gov |
| NOAH MEDICAL Corp. | San Carlos, CA, United States | Specification developer | 1 | March 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| NOAH MEDICAL Corp. | Sunnyvale, CA, United States | Complaint file establishment, Specification developer | 1 | March 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Novatech S.A. | LA CIOTAT CEDEX Bouches-du-Rhone, France | Manufacturer | 1 | February 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 1 | August 31, 2006 | 0 | 0 | 0 | api.fda.gov |
| OTU Medical Inc | Union City, CA, United States | Manufacturer, Specification developer | 1 | June 16, 2022 | 0 | 0 | 0 | api.fda.gov |
| Serpex Medical, Inc. | Santa Clara, CA, United States | Complaint file establishment, Specification developer | 1 | August 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | April 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | May 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sanping Image Technology Co., Ltd. | Shenzhen Guangdong, China | Complaint file establishment, Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | May 22, 2009 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | July 19, 1976 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | July 19, 1976 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 1 | February 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang UE Medical Corp. | Xianju Zhejiang, China | Manufacturer | 1 | August 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ackermann Instrumente GMBH | RIETHEIM, WEILHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Addn Solutions GMBH & Co. KG | Wurmlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allwin Medical Devices, Inc. | Anaheim, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambu SDN.BHD. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambu Mexico Operations S.A. DE C.V. | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Britemed Technology Inc. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Cartago | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerpoint Systems LLC | West Valley City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogentix Medical, Inc. | Orangeburg, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Products, LLC. | Ormond Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Consolidated Medical Equipment Company | Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creation Technologies | Everett, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Efer Endoscopy | LA CIOTAT Bouches-du-Rhone, France | Contract 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 | |
| Glaser AG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Broncus Medical Co., Ltd. | Hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hobbs Medical, Inc. | Stafford Springs, CT, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Endovision, Inc. | Charlton, MA, United States | Contract manufacturer | 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 | |
| Karl Storz Se & Co. KG | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Se & Co. KG | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KH Czechia s.r.o. | Chodov Sokolov, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kunststoff Helmbrechts AG | Helmbrechts Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Wise Optomech Technology Corporation | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract 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 | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qsa Surgical (pvt) Ltd. | SIALKOT Punjab, Pakistan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schott CR, S.R.O. | Valasske Mezirici Zlinsky Kraj, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tochigichizuka Plant | Chizuka, Tochigi, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tontarra Medizintechnik GMBH | WURMLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Puli Ark Medical Technology Co., Ltd | Dongli District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant AS&O Holdings, LLC | Laconia, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 23, 2026. 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.