FDA applicant

Swissray International, Inc.

Elizabeth, NJ3 decisions1997–20071 recall

FDA records 3 decisions for Swissray International, Inc. (Elizabeth, NJ) from 1997 to 2007: 3 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). 1 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 Swissray International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2018

2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Swissray”

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

Swissray Medical AG 4 Swissray Finatech, Inc. 3 Swissray Teleray AG 1

Swissray International, Inc.

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 “Swissray”