Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwedenLabelled 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 14, 2026, FDA's public records list Jolife AB with 5 510(k) clearances and 2 device recalls. The most recent is a device recall dated Apr 13, 2026: LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI cod….
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.
| Apr 13, 2026 | LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 CClass II · Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately d | Device recalls |
| May 21, 2025 | LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have aClass II · Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized fo | Device recalls |
| Feb 8, 2018 | LUCAS 3 Chest Compression SystemK173553 · DRM | 510(k) clearances |
| Nov 9, 2016 | LUCAS 3 Chest Compression SystemK161768 · DRM | 510(k) clearances |
| Jun 17, 2009 | LUCAS 2K090422 · DRM | 510(k) clearances |
| Sep 28, 2006 | MODIFICATION TO LUCASK062401 · DRM | 510(k) clearances |
| Feb 1, 2006 | LUCASK053403 · DRM | 510(k) clearances |
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
