FDA applicant

Jostra Medizintechnik AG

Newark, DE2 decisions2000–20002 recalls

FDA records 2 decisions for Jostra Medizintechnik AG (Newark, DE) in 2000: 2 510(k) clearances. Most are in product codes KFM (Pump, Blood, Cardiopulmonary Bypass…) and DTM (Filter, Blood, Cardiopulmonary Bypass…). 2 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 Jostra Medizintechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jostra Medizintechnik AG since 2007.

Recalls per year

1in 2020

2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Jostra”

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

Jostra AG 14 Jostra Bentley 3

Jostra Medizintechnik AG

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Jostra”