FDA applicant

Biocompatibles UK Limited

South West Ranches, FL7 decisions2004–20160 recalls

FDA records 7 decisions for Biocompatibles UK Limited (South West Ranches, FL) from 2004 to 2016: 7 510(k) clearances. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and HCG (Device, Neurovascular Embolization). Its devices cite 13 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Biocompatibles UK , Ltd.”.

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 Biocompatibles UK Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007high 2 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocompatibles UK Limited’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 “Biocompatibles”

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

Biocompatibles, Inc. 6 Biocompatibles Cardiovascular, Inc. 3 Biocompatibles Eyewear, Inc. 3 Biocompatibles UK Ltd (Part of Boston Scientific… 1

Biocompatibles UK Limited

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?

Other applicant names beginning “Biocompatibles”