510(k) Report

FDA applicant

Collamatrix Co., Inc.

Taipei, TW6 decisions2006–20130 recalls

FDA records 6 decisions for Collamatrix Co., Inc. (Taipei, TW) from 2006 to 2013: 6 510(k) clearances. Most are in product codes KGN (Wound Dressing With Animal-Derived Material (S)) and FRO (Dressing, Wound, Drug). Its devices cite 14 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Collamatrix, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Collamatrix Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007: 12008: 12009: 12010: 12013: 1
2007high 1 (2007) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Collamatrix Co., Inc.’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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