Livanova Deutschland, GmbH
Livanova Deutschland, GmbH holds FDA 510(k) medical device clearances, first cleared 2020, most recent 2023, with 5 FDA device recalls on record.
Top product codes for Livanova Deutschland, GmbH
FDA recalls by Livanova Deutschland, GmbH
- Z-0571-2025 — Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
- Z-0073-2024 — 3T Heater Cooler System, REF: 16-02-85
- Z-0787-2022 — 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.
- Z-2440-2020 — Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
- Z-2439-2020 — Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Livanova Deutschland, GmbH
Data sourced from openFDA. This site is unofficial and independent of the FDA.