Home › Device types › GXY
Electrode, Cutaneous
FDA product code GXY · Class 2 · Neurology
5,377
Registered devices
529
Adverse events
20
Recalls
439
510(k) clearances
Devices with this code
SaeboTrodes Electrodes — SAEBO, INC.Neuroline Cup — Ambu A/SRhythmlink® — RHYTHMLINK INTERNATIONAL, LLCMediMax Tech — MEDIMAX TECH INC.Conductive garment electrode glove sm — BIOMEDICAL LIFE SYSTEMS, INC.Natus — Technomed Engineering B.V.ValuTrode X Foam — AXELGAARD MANUFACTURING CO., LTD.Alpha — Willowwood Global LLCEZ-Stick — COMPASS HEALTH BRANDS CORP.CyMedica TENS Electrodes Set — Motive Health, Inc.Uni-Patch — Cardinal Health, Inc.Ives EEG Solutions — IVES EEG SOLUTIONS, LLCEspire Elbow Pro — COLLEGE PARK INDUSTRIES, INC.AUVON — Shenzhen Yuwen E-Commerce Co., Ltd.QIJIU — Bozhou Rongjian Medical Appliance Co., Ltd.Friendship Medical — Xi'an Friendship Medical Electronics Co.,Ltd.Medical Science Products — NEUROTRON MEDICAL, INC.ScripHessco 2" — COMPASS HEALTH BRANDS CORP.Rhythmlink® — RHYTHMLINK INTERNATIONAL, LLCGrass — NATUS MANUFACTURING LIMITEDGoldSelect™ — Advantage Medical Electronics, LLCRichmar — COMPASS HEALTH BRANDS CORP.UE BioSleeve — AXIOBIONICSEspire Elbow Hybrid — COLLEGE PARK INDUSTRIES, INC.
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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