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Data / Medical devices / Esophagoscope (Flexible Or Rigid)

Esophagoscope (Flexible Or Rigid) (EOX): 31 FDA-registered makers in 10 countries

31 establishments in 10 countries are registered with the FDA to make Esophagoscope (Flexible Or Rigid) (product code EOX, Class 2, 21 CFR 874.4710). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on January 19, 2024, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EOX
Device class
2
Regulation
874.4710
Medical specialty
Ear, Nose, Throat

Makers by country

CountryMakers
United States11
Germany9
Mexico2
Japan2
Switzerland2
Nicaragua1
Dominican Republic1
United Kingdom1
Estonia1
Czechia1

Makers of Esophagoscope (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
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler7January 24, 2020000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer5January 24, 2020000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer3August 29, 2007000api.fda.gov
Cogentix Medical, Inc.Orangeburg, NY, United StatesSpecification developer1November 15, 2018000api.fda.gov
CovidienCiudad Juarez Chihuahua, MexicoManufacturer1August 16, 2018000api.fda.gov
Covidien llcSanta Clara, CA, United StatesSpecification developer1August 16, 2018020api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionKURIHARA-SHI Miyagi, JapanExporter to the US, Manufacturer1December 2, 2022000api.fda.gov
HOYA Corporation PENTAX Lifecare DivisionAkishima-shi Tokyo, JapanComplaint file establishment, Specification developer1December 2, 2022000api.fda.gov
Lucid Diagnostics, Inc.Foxborough, MA, United StatesSpecification developer1February 24, 2023010api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1December 16, 1976000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1December 16, 1976000api.fda.gov
Bruetsch Technology AGBeringen Schaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Coastline de Mexico SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Europlaz Technologies Ltd.Southminster Essex, United KingdomContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Jr-Medizintechnik GMBH & Co KGLeibertingen Baden-Wurttemberg, GermanyContract 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
Raimund Wenzler GMBH, Instrumenten-ManufakturBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Remedy Medical ManufacturingMesa, AZ, United StatesContract manufacturer0000api.fda.gov
Storz Endoskop Produktions GMBHSchaffhausen, SwitzerlandContract manufacturer0000api.fda.gov
Sage Product Development, Inc.Foxborough, MA, United StatesContract manufacturer0000api.fda.gov

Updated January 19, 2024. 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.