4 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
FDA Enforcement
Class II
·Ongoing·LivaNova Deutschland GmbH·December 4, 2024
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
FDA Enforcement
Class II
·Terminated·LivaNova Deutschland GmbH·July 8, 2020
3T Heater Cooler System, REF: 16-02-85
FDA Enforcement
Class II
·Ongoing·LivaNova Deutschland GmbH·October 18, 2023