FDA applicant

Creganna Medical Devices

Northborough, MA1 decision2013–20134 recalls

FDA records 1 decision for Creganna Medical Devices (Northborough, MA) in 2013: 1 510(k) clearance. All are in product code DYB (Introducer, Catheter). Its devices cite 2 predicates, 0 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 Creganna Medical Devices’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

4in 2017

2013high 4 (2017) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Creganna Medical Devices by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Creganna Medical Devices’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

Other applicant names beginning “Creganna”

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

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

Creganna Medical Devices

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Creganna”