510(k) Report

FDA applicant

Stockert Instrumente GmbH

North Attleboro, MA9 decisions2001–20044 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

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

2012: 22019: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stockert Instrumente GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Stockert”

FDA records each applicant name separately; these may or may not be the same firm.