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Data / Medical devices / Device, Neurovascular Embolization / United States

FDA-registered makers of Device, Neurovascular Embolization in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Device, Neurovascular Embolization (product code HCG). 16 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, Neurovascular Embolization
Product code
HCG
Country
United States

Makers of Device, Neurovascular Embolization in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Manufacturer for export, Specification developer23March 29, 2017010api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer13August 14, 2026011api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer11June 24, 2026050api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer10October 25, 2023010api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer10October 25, 2023000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer10October 25, 2023000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer10October 25, 2023000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer7January 27, 2026050api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer6November 7, 2023000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer6November 7, 2023000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer, Manufacturer1May 2, 2008000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer1April 16, 2010000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1April 16, 2010000api.fda.gov
Cerenovus, Inc.Raynham, MA, United StatesManufacturer1December 7, 2006000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1November 13, 1990010api.fda.gov
Wallaby MedicalLaguna Hills, CA, United StatesSpecification developer1May 4, 2018000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
NeuroVasc Technologies, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Nipro Vascular Innovations Americas, Inc.Sunnyvale, CA, United StatesManufacturer for export0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Shape Memory Medical IncSan Jose, CA, United StatesManufacturer for export0000api.fda.gov
Sterigenics US LLCLos Angeles, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer 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.