Home › Device types › GXY
Electrode, Cutaneous
FDA product code GXY · Class 2 · Neurology
5,502
Registered devices
534
Adverse events
20
Recalls
440
510(k) clearances
Devices with this code
waveguard — eemagine Medical Imaging Solutions GmbHThe Electrode Store — IMPULSE MEDICAL TECHNOLOGIES, INC.LSI Silver Self Adhesive, Disposable Electrodes — Drive Devilbiss HealthcareSense System with IBT Electrodes — INFINITE BIOMEDICAL TECHNOLOGIES, LLCAdhesive Electrodes — Drive Devilbiss HealthcareNorco Multi-Use Electrode, Foam — NORTH COAST MEDICAL, INC.GEM-STIM — GEMORE TECHNOLOGY CO., LTD.Chalgren — CHALGREN ENTERPRISESSense System with IBT Electrodes — INFINITE BIOMEDICAL TECHNOLOGIES, LLCSCENAR Cutaneous Electrode Family — OKB RITM, ZAONA — GMDASZ manufacturing Co., Ltd.Norco Multi-Use Electrode, Foam — NORTH COAST MEDICAL, INC.Natus — NATUS NEUROLOGY INCORPORATEDUni-Patch — Cardinal Health 200, LLCNA — GMDASZ manufacturing Co., Ltd.Cadwell Single Disc Electrode — CADWELL INDUSTRIES, INC.TruMedical Self-Adhesive Reusable Electrodes — Drive Devilbiss HealthcareEspire Elbow Hybrid — COLLEGE PARK INDUSTRIES, INC.Therapist’s Choice® — CLINICAL HEALTH SERVICES, INC.Technomed Europe — Technomed Engineering B.V.Compumedics Quik-Cap — COMPUMEDICS LIMITEDNA — GMDASZ manufacturing Co., Ltd.EZ-Stick — Drive Devilbiss HealthcareUni-Patch — Cardinal Health 200, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-02 | Coapt LLC | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. |
| 2023-10-02 | Coapt LLC | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-03-14 | Neuralynx Inc | Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use |
| 2014-04-24 | Medtronic Navigation, Inc. | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devi |
| 2014-04-24 | Medtronic Navigation, Inc. | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devi |
| 2012-02-09 | Covidien LLC dba Uni-Patch | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface |
| 2012-02-09 | Covidien LLC dba Uni-Patch | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface |
| 2012-02-09 | Covidien LLC dba Uni-Patch | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface |
| 2012-02-09 | Covidien LLC dba Uni-Patch | Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface |
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