Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 12 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list LivaNova and its 12 subsidiaries with 265 510(k) clearances and 124 device recalls. The most recent is a 510(k) clearance dated Oct 1, 2026: Dual Stage Venous Cannulae.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, LivaNova and its 12 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 1, 2026 | Dual Stage Venous CannulaeK263092 · DWF | 510(k) clearances |
| Sep 28, 2026 | Tri Stage Venous CannulaeK262052 · DWF | 510(k) clearances |
| Mar 11, 2026 | Venous Return CannulaeK250937 · DWF | 510(k) clearances |
| Jan 30, 2026 | Dual Stage Venous CannulaeK253671 · DWF | 510(k) clearances |
| Dec 22, 2025 | Inspire HCR and HCR DUAL cardiotomy reservoirsK251783 · DTN | 510(k) clearances |
| Dec 19, 2025 | ProtekDilate Vascular Access KitK253616 · DRE | 510(k) clearances |
| Jul 10, 2025 | RAP Femoral Venous CannulaeK250283 · DWF | 510(k) clearances |
| Jun 27, 2025 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250610 · DWF | 510(k) clearances |
| Oct 30, 2017 | CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-ControlClass II · Possibility that the automatic line closure by the Electronic Remote-Controlled (ERC) clamp after detection of an air bu | Device recalls |
| Dec 4, 2013 | S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedClass II · Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pum | Device recalls |
| Dec 4, 2013 | CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for proClass II · Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pum | Device recalls |
| Sep 24, 2013 | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmClass II · Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. | 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
