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Data / Medical devices / Generator, Lesion, Radiofrequency / United States

FDA-registered makers of Generator, Lesion, Radiofrequency in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Generator, Lesion, Radiofrequency (product code GXD). 13 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Generator, Lesion, Radiofrequency
Product code
GXD
Country
United States

Makers of Generator, Lesion, Radiofrequency in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott MedicalPlano, TX, United StatesComplaint file establishment, Specification developer4January 21, 2022000api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesSpecification developer4January 21, 2022020api.fda.gov
Avanos Medical, Inc.Alpharetta, GA, United StatesSpecification developer3August 14, 2024010api.fda.gov
Boston Scientific Neuromodulation CorporationValencia, CA, United StatesComplaint file establishment, Specification developer3August 7, 2025000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesManufacturer2August 7, 2025000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer2October 21, 2020010api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer2January 21, 2022000api.fda.gov
Epimed International, Inc.Johnstown, NY, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 24, 2024000api.fda.gov
Epimed International, Inc.Dallas, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1May 24, 2024000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer1January 2, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1January 2, 2019000api.fda.gov
Neuroone Medical Technologies Corp.Eden Prairie, MN, United StatesComplaint file establishment, Specification developer1December 6, 2023000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1May 25, 2017000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Qxmedical, LLCSaint Paul, MN, United StatesContract manufacturer0000api.fda.gov
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTechOlathe, KS, United StatesContract manufacturer0000api.fda.gov
Spectra Medical Devices, LLCWilmington, MA, United StatesManufacturer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Stellartech Research Corp.Milpitas, CA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.