3 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Enforcement
Class III
·Terminated·LivaNova USA Inc.·February 19, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
FDA Enforcement
Class III
·Terminated·LivaNova USA Inc.·March 4, 2020
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA Enforcement
Class III
·Terminated·LivaNova USA Inc.·July 29, 2020