2 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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 Enforcement
Class II
·Terminated·Uromedica Inc.·May 6, 2020
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
FDA Enforcement
Class II
·Terminated·Uromedica Inc.·January 12, 2022