FDA applicant

Specialty Fibres and Materials, Ltd.

Coventry, GB2 decisions2008–20181 recall

FDA records 2 decisions for Specialty Fibres and Materials, Ltd. (Coventry, GB) from 2008 to 2018: 2 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). 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

How often FDA has decided Specialty Fibres and Materials, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2015

2008high 1 (2015) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Specialty Fibres and Materials, Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Specialty Fibres and Materials, Ltd.’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 “Specialty”

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

Specialty Surgical Products, Inc. 13 Specialty Ultravision, Inc. 12 Specialty Packaging Producs, Inc. 11 Specialty Medical Products Co. 4 Specialty Appliance Works, Inc. 3 Specialty Medical Industries, Inc. 3 Specialty Water Technologies 2 Specialty Spine Products, LLC 2 Specialty Health Products, Inc. 2 Specialty Dialysis Services 1 Specialty Drives Technologies, Inc. 1 Specialty Tint 1

Specialty Fibres and Materials, Ltd.

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 “Specialty”