FDA applicant

Brivant Limited (Lake Region Medical)

Galway, IE1 decision2019–20190 recalls

FDA records 1 decision for Brivant Limited (Lake Region Medical) (Galway, IE) in 2019: 1 510(k) clearance. All are in product code DQX (Wire, Guide, Catheter). 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, cardiovascular panel, where it files most

How often FDA has decided Brivant Limited (Lake Region Medical)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Brivant Limited (Lake Region Medical) by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Brivant Limited (Lake Region Medical)’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 “Brivant”

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

Brivant, Ltd. 9

Brivant Limited (Lake Region Medical)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Brivant”