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Data / Medical devices / Device, Vascular, For Promoting Embolization

Device, Vascular, For Promoting Embolization (KRD): 61 FDA-registered makers in 12 countries

61 establishments in 12 countries are registered with the FDA to make Device, Vascular, For Promoting Embolization (product code KRD, Class 2, 21 CFR 870.3300). 41 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 133 510(k) clearances under this code, the latest on October 6, 2026, and lists 13 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.

Product code
KRD
Device class
2
Regulation
870.3300
Medical specialty
Cardiovascular
Implant
Yes

Makers by country

CountryMakers
United States35
Mexico5
China5
Ireland4
Costa Rica3
Canada2
Japan2
France1
Netherlands1
Denmark1
Vietnam1
Switzerland1

Makers of Device, Vascular, For Promoting Embolization

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
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Manufacturer for export, Specification developer15December 21, 2022030api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer10June 27, 2023000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export8August 3, 2016030api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaSpecification developer6June 27, 2023000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer6June 27, 2023000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer5June 27, 2023000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer5June 24, 2026000api.fda.gov
Abbott MedicalPlymouth, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export4June 12, 2012000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesManufacturer for export, Specification developer4June 12, 2012000api.fda.gov
Biosphere Medical, S.A.Roissy Val-d'Oise, FranceContract manufacturer, Manufacturer4November 21, 2019000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer4December 16, 2016011api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer4April 22, 2015000api.fda.gov
Okami Medical Inc.Aliso Viejo, CA, United StatesManufacturer4April 10, 2026000api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer4June 12, 2012000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer4April 22, 2015000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer3June 27, 2023000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer3February 9, 2021000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer3February 27, 2009000api.fda.gov
Varian Medical Systems, IncAustin, TX, United StatesManufacturer, Repackager or relabeler3January 17, 2025000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer2May 30, 2025020api.fda.gov
Shape Memory Medical IncSan Jose, CA, United StatesManufacturer, Manufacturer for export2May 23, 2019000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer2January 19, 2018000api.fda.gov
Abk BiomedicalHalifax Nova Scotia, CanadaComplaint file establishment, Manufacturer1February 13, 2024000api.fda.gov
Boston Scientific International BV, European Dist. Ctr.KERKRADE Limburg, NetherlandsManufacturer1August 7, 2014000api.fda.gov
Canyon Medical Inc.Nanjing Jiangsu, ChinaManufacturer1September 23, 2025000api.fda.gov
Embolization IncBoulder, CO, United StatesComplaint file establishment, Manufacturer1May 15, 2025000api.fda.gov
Imbiotechnologies LtdEdmonton Alberta, CanadaComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 10, 2010000api.fda.gov
KA MedicalArden Hills, MN, United StatesContract manufacturer, Manufacturer1April 17, 2019000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1August 11, 1988000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Specification developer1May 2, 2024010api.fda.gov
Nuvascular Inc.Irvine, CA, United StatesManufacturer1July 9, 2025000api.fda.gov
Obsidio IncMaple Grove, MN, United StatesManufacturer1October 3, 2024000api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer1March 14, 2025000api.fda.gov
Penumbra Costa Rica, S.R.L.Guadalupe Cartago, Costa RicaManufacturer1March 14, 2025000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer1March 14, 2025000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer1March 14, 2025000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer1March 14, 2025000api.fda.gov
Suzhou Haowei Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1November 14, 2023000api.fda.gov
Suzhou Hengrui Hongyuan Medical Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1October 1, 2021000api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer1April 17, 2012010api.fda.gov
William Cook Europe ApsBJAEVERSKOV Sjaelland, DenmarkComplaint file establishment, Manufacturer1December 18, 2015000api.fda.gov
Amphenol Alden Products CompanyHermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer0000api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoManufacturer0000api.fda.gov
Isomedix Operations, Inc.Minneapolis, MN, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
KANEKA MEDICAL VIETNAM Co.,Ltd.Ho Chi Minh, VietnamManufacturer0000api.fda.gov
Kaneka Medix Corporation Kanagawa PlantAshigara-Kami-gun Kanagawa, JapanManufacturer0000api.fda.gov
Kaneka Corporation Osaka PlantSettsu-shi Osaka, JapanExporter to the US, Specification developer0000api.fda.gov
Medical Murray, Inc.Lake Zurich, IL, United StatesContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Merit Medical Ireland, LtdGalway Galway(County), IrelandContract manufacturer0000api.fda.gov
Microport Neurotech (shanghai) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Microport Neurotech (shanghai) Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Sterigenics Radiation Technologies, LLCSan Diego, CA, United StatesManufacturer for export0000api.fda.gov
Sterigenics U.S., LLCSalt Lake City, UT, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Stryker NeurovascularCork Munster, IrelandManufacturer0000api.fda.gov

Updated October 6, 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.