Data / Medical devices / System, Endovascular Graft, Aortic Aneurysm Treatment

System, Endovascular Graft, Aortic Aneurysm Treatment (MIH): 21 FDA-registered makers in 8 countries

Name: FDA-registered makers of System, Endovascular Graft, Aortic Aneurysm Treatment
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in 8 countries are registered with the FDA to make System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH, Class 3). 13 of them have a 510(k) clearance or PMA approval on file and 7 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 44 recall events (7 Class I). FDA data exported November 2, 2026.

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Product code: MIH
Device class: 3
Medical specialty: Unknown
Implant: Yes

Makers by country

Country	Makers
United States	11
Mexico	4
Ireland	1
Denmark	1
Australia	1
Costa Rica	1
Dominican Republic	1
Vietnam	1

Makers of System, Endovascular Graft, Aortic Aneurysm Treatment

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	PMA approvals	Recall events	Class I	Source
Bolton Medical, Inc.	Sunrise, FL, United States	Manufacturer, Manufacturer for export	3	4	1	api.fda.gov
W. L. Gore & Associates, Inc	Flagstaff, AZ, United States	Manufacturer	3	6	0	api.fda.gov
Endologix LLC	Santa Rosa, CA, United States	Complaint file establishment, Manufacturer, Specification developer	2	4	2	api.fda.gov
Medtronic Ireland	GALWAY Galway(County), Ireland	Manufacturer	2	0	0	api.fda.gov
Medtronic Mexico Eg	EMPALME Sonora, Mexico	Manufacturer	2	0	0	api.fda.gov
Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, Mexico	Manufacturer	2	0	0	api.fda.gov
Medtronic Vascular	Santa Rosa, CA, United States	Specification developer	2	2	0	api.fda.gov
W. L. Gore & Associates, Inc.	Phoenix, AZ, United States	Manufacturer	2	1	0	api.fda.gov
William Cook Europe Aps	BJAEVERSKOV Sjaelland, Denmark	Complaint file establishment, Manufacturer	2	0	0	api.fda.gov
Cook Incorporated	Bloomington, IN, United States	Complaint file establishment, Manufacturer	1	7	0	api.fda.gov
Endologix LLC	Irvine, CA, United States	Manufacturer	1	8	1	api.fda.gov
W. L. Gore & Associates, Inc.	Santa Clara, CA, United States	Manufacturer	1	0	0	api.fda.gov
William A. Cook Australia Pty, Ltd.	EIGHT MILE PLAINS Queensland, Australia	Complaint file establishment, Manufacturer	1	0	0	api.fda.gov
Aptyx - Charlotte	Charlotte, NC, United States	Manufacturer for export	0	0	0	api.fda.gov
Biomerics Alajuela	Alajuela, Costa Rica	Contract manufacturer	0	0	0	api.fda.gov
Carwild Corp.	New London, CT, United States	Contract manufacturer	0	0	0	api.fda.gov
Cardinal Health Mexico 244 S de RL de CV	Ciudad Juarez Chihuahua, Mexico	Manufacturer	0	0	0	api.fda.gov
Medsorb Dominicana, S.A.	San Pedro De Macoris, Dominican Republic	Contract manufacturer	0	0	0	api.fda.gov
SEI Medical S.A. de C.V.	Juarez Chihuahua, Mexico	Contract manufacturer	0	0	0	api.fda.gov
Sterigenics U.S. LLC	Mulberry, FL, United States	Contract sterilizer, Manufacturer for export	0	0	0	api.fda.gov
Terumo Vietnam Co., Ltd	Hanoi City Ha Noi, Vietnam	Contract manufacturer	0	0	0	api.fda.gov

Updated November 2, 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.