Company ยท DE
Beckman Coulter Biomedical GmbH
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2019. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
7recalls (1 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2026 | Beckman Coulter Biomedical GmbH REMISOL Advance with Software Version 2.5
UDI-DI code: 15099590802073
The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections Open, Classified |
JQP | None listed |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express. Open, Classified |
CDD | K140496 |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge, REF: B36365, a component of the Power Express Open, Classified |
CDD | K140496 |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH Power Express, REF B90918 Open, Classified |
CDD | K140496 |
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | K190298 |
| Jul 14, 2023 | Beckman Coulter Biomedical GmbH Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Open, Classified |
JJE | K190298 |
| Jun 17, 2020 | Beckman Coulter Biomedical GmbH DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample pro Terminated |
JJE | K190298 |