FDA applicant
Sorin Group Deutschland GmbH
FDA records 20 decisions for Sorin Group Deutschland GmbH (North Attleboro, MA) from 2006 to 2017: 20 510(k) clearances. Most are in product codes DTQ (Console, Heart-Lung Machine, Cardiopulmonary…) and DWA (Control, Pump Speed, Cardiopulmonary Bypass). Its devices cite 24 predicates, 9 of them its own earlier devices. 59 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sorin Group Deutschland GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Sorin Group Deutschland GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sorin”
FDA records each applicant name separately; these may or may not be the same firm.