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Data / Medical devices / Prosthesis, Tracheal, Expandable

Prosthesis, Tracheal, Expandable (JCT): 14 FDA-registered makers in 4 countries

14 establishments in 4 countries are registered with the FDA to make Prosthesis, Tracheal, Expandable (product code JCT, Class 2, 21 CFR 878.3720). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 45 510(k) clearances under this code, the latest on July 14, 2023, and lists 9 recall events (1 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 the United StatesWatch this device
Product code
JCT
Device class
2
Regulation
878.3720
Medical specialty
General, Plastic Surgery
Implant
Yes
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States7
South Korea4
China2
Ireland1

Makers of Prosthesis, Tracheal, Expandable

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
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer4September 21, 2018000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer3July 8, 2022000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer3July 8, 2022000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2July 14, 2023030api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2July 14, 2023000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer, Specification developer2July 14, 2023000api.fda.gov
Atrium Medical CorporationMerrimack, NH, United StatesManufacturer1May 6, 2005021api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1December 18, 1991000api.fda.gov
M.i.tech Co., Ltd.Jeonju Jeonbuk, South KoreaManufacturer1December 31, 2020000api.fda.gov
M.I.Tech Co LtdPyeongtaek Gyeonggi, South KoreaManufacturer1December 31, 2020000api.fda.gov
M.I.Tech Co., Ltd.Seoul, South KoreaSpecification developer1December 31, 2020000api.fda.gov
Sewoon Medical Co., Ltd.Cheonan-si Chungnam, South KoreaManufacturer1October 17, 2014000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
Oxford Performance Materials, Inc.South Windsor, CT, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov

Updated July 14, 2023. 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.