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Data / Medical devices / Catheter, Electrode Recording, Or Probe, Electrode Recording / United States

FDA-registered makers of Catheter, Electrode Recording, Or Probe, Electrode Recording in the United States: 33 establishments

33 establishments in the United States are registered with the FDA to make Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF). 21 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Electrode Recording, Or Probe, Electrode Recording
Product code
DRF
Country
United States

Makers of Catheter, Electrode Recording, Or Probe, Electrode Recording in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer26January 26, 2022100api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Specification developer21September 17, 2019000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer13December 2, 2023010api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer12September 17, 2019000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer11June 27, 2025000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer11June 27, 2025000api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer8July 30, 2019000api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export, Specification developer7August 13, 2010010api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer, Manufacturer for export, Specification developer7July 15, 2015000api.fda.gov
Innovative Health, LLC.Scottsdale, AZ, United StatesReprocessor3March 5, 2021000api.fda.gov
Synaptic Medical CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer3September 6, 2024000api.fda.gov
Access Point Technologies, Ep Inc.Rogers, MN, United StatesComplaint file establishment, Manufacturer2July 23, 2025000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer2August 8, 1995000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer2August 8, 1995010api.fda.gov
Arrow International, LLC (subsidiary of Teleflex, Incorporated)Chelmsford, MA, United StatesManufacturer2August 8, 1995000api.fda.gov
Cardiocommand, Inc.Tampa, FL, United StatesManufacturer2March 29, 1991000api.fda.gov
Alpha Medical Instruments LLCMission Viejo, CA, United StatesManufacturer1April 20, 1998000api.fda.gov
Boston Scientific CorporationWaltham, MA, United StatesSpecification developer1June 10, 2022000api.fda.gov
Imricor Medical SystemsBurnsville, MN, United StatesComplaint file establishment, Manufacturer1January 8, 2026000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1June 30, 1983000api.fda.gov
TZ Medical, Inc.Tualatin, OR, United StatesManufacturer, Repackager or relabeler, Specification developer1April 18, 2003000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Carrio Cabling CorporationColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Harmac Medical Products, Inc.Buffalo, NY, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Nypro Inc (Maple Grove)Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Phillips-Medisize Costa Mesa LLCCosta Mesa, CA, United StatesContract manufacturer0000api.fda.gov
Sterilmed, Inc.Plymouth, MN, United StatesReprocessor, Specification developer0000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Technical Services For Electronics, Inc.Jackson, MN, United StatesContract manufacturer0000api.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.