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Electrode, Electrocardiograph

FDA product code DRX · Class 2 · Cardiovascular

2,297
Registered devices
1,721
Adverse events
20
Recalls
329
510(k) clearances

Devices with this code

Ambu WhiteSensor 4560MECG Electrodes — Ambu A/SZ-Brand™ — GRAPHIC CONTROLS ACQUISITION CORPAmbu WhiteSensor — MEDICO ELECTRODES INTERNATIONAL LIMITEDECG — Zoll Medical CorporationCLEARTRACE — Conmed CorporationSilverTRACE — Carefusion Finland 320 OyMed-Dyne — MED-DYNE, INC.L.M.C Associates, Inc. — GRAPHIC CONTROLS ACQUISITION CORPAPK — APK Technology Co.,Ltd.Medline — MEDLINE INDUSTRIES, INC.Henry Schein — HENRY SCHEIN, INC.SWAROMED — TYROLMED GmbHAccuSensor — Lynn Medical Instrument Co.APK — APK Technology Co.,Ltd.VersaTrode™ — GRAPHIC CONTROLS ACQUISITION CORPKendall — Cardinal Health 200, LLCAMC — LifeSync CorporationMediMax Tech — MEDIMAX TECH INC.MediMax Tech — MEDIMAX TECH INC.EKG Patch (Pediatric 2) — Mg Medical Products LLCezPad MRI — MIPM Mammendorfer Institut für Physik und Medizin GmbHQT ECG — Qt Medical, Inc.NA — FIAB SPAQT ECG — Qt Medical, Inc.

Recent recalls

DateFirmReason
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2022-03-15Graphic Controls Acquisition CorporationInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of
2021-10-063M Company - Health Care BusinessPotential for breakage of the ECG electrode carbon stud from the eyelet.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.