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

FDA-registered makers of Device, Vascular, For Promoting Embolization in the United States: 35 establishments

35 establishments in the United States are registered with the FDA to make Device, Vascular, For Promoting Embolization (product code KRD). 27 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Device, Vascular, For Promoting Embolization
Product code
KRD
Country
United States

Makers of Device, Vascular, For Promoting Embolization in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Manufacturer for export, Specification developer15December 21, 2022030api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export8August 3, 2016030api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer6June 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
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer4December 16, 2016011api.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
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
Embolization IncBoulder, CO, United StatesComplaint file establishment, Manufacturer1May 15, 2025000api.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 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
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer1April 17, 2012010api.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
Isomedix Operations, Inc.Minneapolis, MN, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Medical Murray, Inc.Lake Zurich, IL, United StatesContract 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

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.