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Data / Medical devices / Catheter, Ultrasound, Intravascular / United States

FDA-registered makers of Catheter, Ultrasound, Intravascular in the United States: 28 establishments

28 establishments in the United States are registered with the FDA to make Catheter, Ultrasound, Intravascular (product code OBJ). 16 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Ultrasound, Intravascular
Product code
OBJ
Country
United States

Makers of Catheter, Ultrasound, Intravascular in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer10June 28, 2024000api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer7September 2, 2020020api.fda.gov
Siemens Medical Solutions Usa, Inc.Issaquah, WA, United StatesComplaint file establishment, Manufacturer, Specification developer6September 10, 2026010api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer6May 22, 2020050api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer5July 8, 2014050api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer, Specification developer4May 23, 2025000api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Specification developer4May 23, 2025000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler4September 26, 2013000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Manufacturer, Specification developer3March 20, 2020011api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer3May 23, 2025000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer2April 8, 2026010api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesManufacturer1January 18, 2013011api.fda.gov
Northeast Scientific, Inc.Waterbury, CT, United StatesComplaint file establishment, Manufacturer1June 22, 2020000api.fda.gov
Provisio Medical Inc.San Diego, CA, United StatesManufacturer1April 23, 2024000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer, Reprocessor, Specification developer1May 23, 2025000api.fda.gov
Yorlabs, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1October 22, 2025000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer0010api.fda.gov
Ge Parallel Design, Inc.Phoenix, AZ, United StatesManufacturer0000api.fda.gov
Innovative Health, LLC.Scottsdale, AZ, United StatesReprocessor0000api.fda.gov
Nipro Vascular Innovations Americas, Inc.Bedford, MA, United StatesManufacturer0000api.fda.gov
Pathway Medtech, LLC.Santee, CA, United StatesContract manufacturer0000api.fda.gov
Philips Ultrasound LLCReedsville, PA, United StatesManufacturer0000api.fda.gov
Philips Ultrasound LLCCambridge, MA, United StatesSpecification developer0000api.fda.gov
Philips Ultrasound LLCBothell, WA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Sound Technology Inc.State College, PA, United StatesManufacturer0000api.fda.gov
Siemens Medical Solutions USA, Inc.Plymouth Meeting, PA, United StatesManufacturer, Specification developer0000api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer0000api.fda.gov
Stryker Sustainability Solutions PhoenixPhoenix, AZ, United StatesReprocessor0000api.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.