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
| Country | Makers |
|---|---|
| United States | 11 |
| Germany | 9 |
| Mexico | 2 |
| Japan | 2 |
| Switzerland | 2 |
| Nicaragua | 1 |
| Dominican Republic | 1 |
| United Kingdom | 1 |
| Estonia | 1 |
| Czechia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Karl Storz Endoscopy-America, Inc. | Auburn, MA, United States | Contract manufacturer, Repackager or relabeler | 7 | January 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Se & Co KG | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer | 5 | January 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 3 | August 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Cogentix Medical, Inc. | Orangeburg, NY, United States | Specification developer | 1 | November 15, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 1 | August 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Covidien llc | Santa Clara, CA, United States | Specification developer | 1 | August 16, 2018 | 0 | 2 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | KURIHARA-SHI Miyagi, Japan | Exporter to the US, Manufacturer | 1 | December 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| HOYA Corporation PENTAX Lifecare Division | Akishima-shi Tokyo, Japan | Complaint file establishment, Specification developer | 1 | December 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Lucid Diagnostics, Inc. | Foxborough, MA, United States | Specification developer | 1 | February 24, 2023 | 0 | 1 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | December 16, 1976 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | December 16, 1976 | 0 | 0 | 0 | api.fda.gov |
| Bruetsch Technology AG | Beringen Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Command Medical Nicaragua SA | Managua, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coastline de Mexico SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Europlaz Technologies Ltd. | Southminster Essex, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | 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 | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jr-Medizintechnik GMBH & Co KG | Leibertingen Baden-Wurttemberg, Germany | Contract 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 | |
| Raimund Wenzler GMBH, Instrumenten-Manufaktur | BALGHEIM Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remedy Medical Manufacturing | Mesa, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storz Endoskop Produktions GMBH | Schaffhausen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sage Product Development, Inc. | Foxborough, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.