Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of LivaNovaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list LivaNova Deutschland GmbH with 7 510(k) clearances and 5 device recalls. The most recent is a device recall dated Oct 18, 2024: Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 18, 2024 | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with SoftwareClass II · Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before | Device recalls |
| Aug 24, 2023 | Essenz HLM, Essenz ILBMK232291 · DTQ | 510(k) clearances |
| Aug 3, 2023 | 3T Heater Cooler System, REF: 16-02-85Class II · The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Co | Device recalls |
| Mar 9, 2023 | Essenz HLMK221373 · DTQ | 510(k) clearances |
| Nov 16, 2022 | Heater-Cooler System 3TK220635 · DWC | 510(k) clearances |
| Dec 17, 2021 | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A Class III · One ferrite ring expected to be installed on centrifugal pump system power cable may not be present. | Device recalls |
| Nov 10, 2021 | ESSENZ Patient MonitorK212003 · DXJ | 510(k) clearances |
| Apr 5, 2021 | Stockert S5 SystemK210130 · DTQ | 510(k) clearances |
| Apr 1, 2021 | B-CaptaK202154 · DRY | 510(k) clearances |
| Feb 25, 2020 | Heater-Cooler System 3TK191402 · DWC | 510(k) clearances |
| Aug 26, 2019 | Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986Class II · The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump | Device recalls |
| Aug 26, 2019 | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993Class II · The SCP control Panel rotary knob used to control rotary speed of the pump in the SCP system used as a centrifugal pump | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
