6 results
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61ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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ORCHESTRA/ORCHESTRA PLUS Programmer
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·January 29, 2014
Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·September 30, 2020
Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·September 30, 2020
Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·September 30, 2020
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·September 30, 2020
Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
FDA Enforcement
Class II
·Terminated·Sorin Group Italia S.r.l.·September 30, 2020