FDA applicant

Creganna Medical Aslo Business AS Cregganna Tactx Medical

Galway, IE2 decisions2016–20171 recall

FDA records 2 decisions for Creganna Medical Aslo Business AS Cregganna Tactx Medical (Galway, IE) from 2016 to 2017: 2 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQY (Catheter, Percutaneous). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Creganna Medical Aslo Business AS Cregganna Tactx Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2023

2016high 1 (2023) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Creganna Medical Aslo Business AS Cregganna Tactx Medical by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Creganna Medical Aslo Business AS…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Creganna”

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

Creganna-Tactx Medical 2 Creganna Medical Also Doing Business AS Ceganna Tactx… 1 Creganna Medical Devices 1

Creganna Medical Aslo Business AS Cregganna Tactx Medical

Which product codes does it file in?

Whose devices does it build on?

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 “Creganna”