FDA applicant

Kretztechnik AG

Austria, AT6 decisions1990–19930 recalls

FDA records 6 decisions for Kretztechnik AG (Austria, AT) from 1990 to 1993: 6 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Kretztechnik AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kretztechnik AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kretztechnik AG’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) Report

Kretztechnik AG

Which product codes does it file in?

What has FDA decided for it lately?