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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

CountryMakers
United States33
China17
Japan11
Germany10
Mexico6
Malaysia5
Costa Rica4
France3
Canada2
Israel2
Taiwan2
Czechia2
Denmark1
Ireland1
Vietnam1
United Kingdom1
Nicaragua1
Estonia1
Pakistan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer23April 23, 2026000api.fda.gov
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler13December 5, 2025000api.fda.gov
Aizu Olympus Co., Ltd.AIZUWAKAMATSU-SHI Fukushima, JapanManufacturer11April 23, 2026020api.fda.gov
FUJIFILM Corporation Medical Systems Research & Development Center KaiseiAshigarakami-Gun Kanagawa, JapanComplaint file establishment, Manufacturer, Specification developer11June 16, 2026000api.fda.gov
FUJIFILM Healthcare Manufacturing Corporation Sano OfficeSano City Tochigi, JapanManufacturer11June 16, 2026000api.fda.gov
Intuitive Surgical, Inc.Sunnyvale, CA, United StatesSpecification developer11September 23, 2025050api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer11December 5, 2025000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer10June 4, 2025010api.fda.gov
Ambu A/SBallerup Hovedstaden, DenmarkSpecification developer9September 16, 2026000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer9January 18, 2024000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer8October 21, 2021000api.fda.gov
Hunan Vathin Medical Instrument Co., Ltd.Xiangtan Hunan, ChinaExporter to the US, Manufacturer7July 25, 2025000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer6March 2, 2023000api.fda.gov
Auris Health, IncSanta Clara, CA, United StatesManufacturer, Specification developer5July 25, 2026040api.fda.gov
Auris Health, Inc.San Jose, CA, United StatesManufacturer, Repackager or relabeler5July 25, 2026000api.fda.gov
Broncus Medical IncSan Jose, CA, United StatesManufacturer5May 31, 2024000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer5June 15, 2023010api.fda.gov
Verathon Medical (canada) ULCBurnaby British Columbia, CanadaSpecification developer5May 3, 2023000api.fda.gov
Verathon Medical (canada) ULC.BURNABY British Columbia, CanadaManufacturer5May 3, 2023000api.fda.gov
Intuitive Surgical, Inc.Santa Clara, CA, United StatesManufacturer4September 23, 2025000api.fda.gov
Scivita Medical Technology Co., Ltd.suzhou Jiangsu, ChinaManufacturer4March 19, 2025000api.fda.gov
Covidien llcPlymouth, MN, United StatesManufacturer, Specification developer3April 21, 2017000api.fda.gov
Axess Vision TechnologyJoue Les Tours Indre-et-Loire, FranceManufacturer2February 16, 2022000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2March 8, 2019000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer2March 8, 2019000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer2November 22, 1994010api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer2November 22, 1994000api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.Mexicali Baja California, MexicoExporter to the US, Manufacturer2April 3, 2024000api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.Mexicali Baja California, MexicoExporter to the US, Manufacturer2April 3, 2024000api.fda.gov
Macrolux Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer2April 8, 2026000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer2May 30, 2025000api.fda.gov
Shanghai AnQing Medical Instrument Co., LtdShanghai, ChinaExporter to the US, Manufacturer2May 29, 2025000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1April 29, 2021000api.fda.gov
Body Vision Medical LtdNetanya Tel Aviv, IsraelManufacturer1April 26, 2018000api.fda.gov
Body Vision Medical Lungvision Tool ManufacturingNetanya Northern, IsraelManufacturer1April 26, 2018000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1March 27, 2017000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer1March 8, 2019000api.fda.gov
Contra Healthcare Solutions LLCButler, PA, United StatesManufacturer, Specification developer1April 30, 2025000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer1September 2, 2026000api.fda.gov
HaradaOsaka, JapanSpecification developer1March 12, 1986000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler1August 12, 2002000api.fda.gov
Hunan Endoso Life Technology Co., LtdXiangTan Hunan, ChinaManufacturer1February 15, 2024000api.fda.gov
Medimaging Integrated Solution Inc.Hsinchu Hsinchu(City), TaiwanExporter to the US, Manufacturer1May 1, 2024000api.fda.gov
Mercator Medsystems, Inc.San Leandro, CA, United StatesManufacturer1July 2, 2013000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer1July 8, 2022000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer1July 8, 2022000api.fda.gov
NOAH MEDICAL Corp.San Jose, CA, United StatesManufacturer1March 1, 2023050api.fda.gov
NOAH MEDICAL Corp.San Carlos, CA, United StatesSpecification developer1March 1, 2023000api.fda.gov
NOAH MEDICAL Corp.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer1March 1, 2023000api.fda.gov
Novatech S.A.LA CIOTAT CEDEX Bouches-du-Rhone, FranceManufacturer1February 6, 2025000api.fda.gov
OLYMPUS MEDICAL SYSTEMS CORP. Hinode PlantNISHITAMA-GUN Tokyo, JapanManufacturer1August 31, 2006000api.fda.gov
OTU Medical IncUnion City, CA, United StatesManufacturer, Specification developer1June 16, 2022000api.fda.gov
Serpex Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer1August 15, 2022000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer1April 11, 2023000api.fda.gov
Shenzhen Insighters Medical Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer1May 28, 2025000api.fda.gov
Shenzhen Sanping Image Technology Co., Ltd.Shenzhen Guangdong, ChinaComplaint file establishment, Manufacturer1March 14, 2025000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesSpecification developer1May 22, 2009000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1July 19, 1976000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1July 19, 1976000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1February 21, 2018000api.fda.gov
Zhejiang UE Medical Corp.Xianju Zhejiang, ChinaManufacturer1August 11, 2025000api.fda.gov
Ackermann Instrumente GMBHRIETHEIM, WEILHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
Ambu SDN.BHD.PENANG Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Ambu Mexico Operations S.A. DE C.V.Ciudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Britemed Technology Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Biomerics CartagoCartago, Costa RicaContract manufacturer0000api.fda.gov
Centerpoint Systems LLCWest Valley City, UT, United StatesContract manufacturer0000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesSpecification developer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Creation TechnologiesEverett, WA, United StatesContract manufacturer0000api.fda.gov
Efer EndoscopyLA CIOTAT Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Glaser AGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Guangdong MacroLux Medical Technology Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Hangzhou Broncus Medical Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Video Endoscopy Estonia OueLaagri Harjumaa, EstoniaContract manufacturer0000api.fda.gov
KH Czechia s.r.o.Chodov Sokolov, CzechiaContract manufacturer0000api.fda.gov
Kunststoff Helmbrechts AGHelmbrechts Bavaria, GermanyContract manufacturer0000api.fda.gov
Ningbo Wise Optomech Technology CorporationNingbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Plexus Manufacturing Sdn.Bhd.Bayan Lepas Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Polimeros Formula de Tecate S.A de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Qsa Surgical (pvt) Ltd.SIALKOT Punjab, PakistanContract manufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Schott CR, S.R.O.Valasske Mezirici Zlinsky Kraj, CzechiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Tochigichizuka PlantChizuka, Tochigi, JapanContract manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Tianjin Puli Ark Medical Technology Co., LtdDongli District Tianjin, ChinaContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCLaconia, NH, United StatesContract manufacturer0000api.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.