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Data / Medical devices / Prosthesis, Esophageal

Prosthesis, Esophageal (ESW): 16 FDA-registered makers in 4 countries

16 establishments in 4 countries are registered with the FDA to make Prosthesis, Esophageal (product code ESW, Class 2, 21 CFR 878.3610). 13 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on July 10, 2026, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in South KoreaWatch this device
Product code
ESW
Device class
2
Regulation
878.3610
Medical specialty
General, Plastic Surgery
Implant
Yes

Makers by country

CountryMakers
South Korea6
United States6
Ireland2
China2

Makers of Prosthesis, Esophageal

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
Taewoong Medical Co., LtdGimpo-Si Gyeonggi, South KoreaManufacturer7October 30, 2025010api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer4April 29, 2024030api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer4April 29, 2024000api.fda.gov
M.i.tech Co., Ltd.Jeonju Jeonbuk, South KoreaManufacturer4October 30, 2025000api.fda.gov
M.I.Tech Co LtdPyeongtaek Gyeonggi, South KoreaManufacturer4October 30, 2025000api.fda.gov
M.I.Tech Co., Ltd.Seoul, South KoreaSpecification developer4October 30, 2025000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer3April 29, 2024010api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer3July 23, 2025000api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer2December 21, 2016000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer2May 29, 2019000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer2May 29, 2019000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1April 4, 2024000api.fda.gov
Sewoon Medical Co., Ltd.Cheonan-si Chungnam, South KoreaManufacturer1February 22, 2010000api.fda.gov
Allwin Medical Devices, Inc.Anaheim, CA, United StatesManufacturer for export0000api.fda.gov
BCM Co., Ltd.Goyang-si Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov

Updated July 10, 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.