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AUVON

Shenzhen Yuwen E-Commerce Co., Ltd. · Model CG2252 · UDI-DI 16971292006746

GYB
10
510(k) clearances
138
Adverse events (1 deaths)
10
Recalls
58
Facilities

Description

Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.

Recalls

DateFirmReason
2024-03-22Parker Laboratories, Inc.Product demonstrates low viscosity.
2024-02-07Natus Neurology IncNatus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Numb
2024-02-07Natus Neurology IncNatus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a voluntary recall related to their Tensive Conductive Adhesive Gel, Ref. 22-60 Lot Numb
2024-01-22Parker Laboratories, Inc.Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
2021-08-24National Distribution & Contracting IncUltrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
2019-06-19Pharmaceutical Innovations, Inc.Potential for failed stability antimicrobial effectiveness testing.
2019-06-19Pharmaceutical Innovations, Inc.Potential for failed stability antimicrobial effectiveness testing.
2019-06-19Pharmaceutical Innovations, Inc.Potential for failed stability antimicrobial effectiveness testing.
2019-06-19Pharmaceutical Innovations, Inc.Potential for failed stability antimicrobial effectiveness testing.
2019-06-19Pharmaceutical Innovations, Inc.Potential for failed stability antimicrobial effectiveness testing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.