FDA applicant
Stockert Instrumente GmbH
FDA records 9 decisions for Stockert Instrumente GmbH (North Attleboro, MA) from 2001 to 2004: 9 510(k) clearances. Most are in product codes DWA (Control, Pump Speed, Cardiopulmonary Bypass) and DWF (Catheter, Cannula And Tubing, Vascular…). Its devices cite 8 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Stockert Instrumente GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Stockert Instrumente GmbH since 2007.
Recalls per year
2in 2019
Class I Class II/III not classified
Planning a device like Stockert Instrumente 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 “Stockert”
FDA records each applicant name separately; these may or may not be the same firm.