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Electrode, Electrocardiograph

FDA product code DRX · Class 2 · Cardiovascular

2,279
Registered devices
1,587
Adverse events
20
Recalls
329
510(k) clearances

Devices with this code

Z-Brand™ — GRAPHIC CONTROLS ACQUISITION CORPSWAROMED — TYROLMED GmbHNova Plus® — 3M COMPANYEKG Patch (Medium) — Mg Medical Products LLCswaromed — NISSHA MEDICAL TECHNOLOGIES LTDQT ECG — Qt Medical, Inc.Medline — MEDLINE INDUSTRIES, INC.APK — APK Technology Co.,Ltd.Bio Protech — BIO PROTECH USA, INC.AMC — Advantage Medical Electronics, LLCAMC — Advantage Medical Electronics, LLC3M™ Red Dot™ — 3M COMPANYUni-Patch — Cardinal Health, Inc.Skintact — Leonhard Lang GmbHMediMax Tech — MEDIMAX TECH INC.APK — APK Technology Co.,Ltd.NA — FIAB SPAKlear-Trace — TRINITY MEDICAL DEVICES INC.Cardioskin Textile S24 — BIOSERENITY MEDICAL DEVICES GROUPNA — FIAB SPA3M™ — 3M COMPANYMedline — MEDLINE INDUSTRIES, INC.APK — APK Technology Co.,Ltd.Vermed — GRAPHIC CONTROLS ACQUISITION CORP

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.