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Technomed Europe
Technomed Engineering B.V. · Model TE/C32-434 · UDI-DI 08718375860816
GXY
Prescription
10
510(k) clearances
529
Adverse events (1 deaths)
20
Recalls
250
Facilities
Description
Reusable EEG Cup Electrode Gold plated (Au), 12 pieces
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 lots received between 0 |
| 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 only, but the manufa |
| 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 devices were appropriate |
| 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 devices were appropriate |
| 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 of the wires in the |
| 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 of the wires in the |
| 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 of the wires in the |
| 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 of the wires in the |
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Get your free API keyRead the docsData 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.