2 results
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27ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
FDA Recall
Terminated
·Uromedica Inc.·Product code KOA·April 10, 2019
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
FDA Recall
Terminated
·Uromedica Inc.·Product code EZY·November 22, 2021