Company ยท DE
Livanova Deutschland, GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2020 to 2023. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2023 | K232291 | Essenz HLM, Essenz ILBM Livanova Deutschland, GmbH, DE | DTQ |
| Mar 9, 2023 | K221373 | Essenz HLM Livanova Deutschland, GmbH, DE | DTQ |
| Nov 16, 2022 | K220635 | Heater-Cooler System 3T Livanova Deutschland, GmbH, DE | DWC |
| Nov 10, 2021 | K212003 | ESSENZ Patient Monitor Livanova Deutschland, GmbH, DE | DXJ |
| Apr 5, 2021 | K210130 | Stockert S5 System Livanova Deutschland, GmbH, DE | DTQ |
| Apr 1, 2021 | K202154 | B-Capta Livanova Deutschland, GmbH, DE | DRY |
| Feb 25, 2020 | K191402 | Heater-Cooler System 3T Livanova Deutschland, GmbH, DE | DWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2024 | LivaNova Deutschland GmbH Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software Open, Classified |
DTQ | K232291 |
| Oct 6, 2023 | LivaNova Deutschland GmbH 3T Heater Cooler System, REF: 16-02-85 Open, Classified |
DWC | K191402 |
| Dec 17, 2021 | LivaNova Deutschland GmbH Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device. Terminated |
DWA | K112225 |
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI:
04033817900986 Terminated |
DWA | K011838 |
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 Terminated |
DWA | K011838 |