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Neuralynx Recalls
1 recall on record · May 25, 2022 to May 25, 2022 · Medical Devices
May 25, 2022
Medical Devices
FDA
Neuralynx Inc recalls ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Fed
Hazard: 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 manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.
Neuralynx Recalls | RecallWatchUSA