5 results
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37ms
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Sources: EU EUDAMED, US FDA
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
FDA Recall
Terminated
·Tapemark Company·Product code EGJ·November 10, 2021
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.
FDA Enforcement
Class III
·Terminated·Tapemark Company·January 12, 2022
NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
FDA Adverse Event
Injury
·MEDTRONIC DOMINICANA·Product code ETN·September 5, 2025
CUSTOM TUBING PACK
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code DWF·August 27, 2025
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·April 9, 2026