510(k) Report

FDA applicant

Ferrosan Meidcal Devices A/S

Soeborg1 decision1999–19995 recalls

FDA records 1 decision for Ferrosan Meidcal Devices A/S (Soeborg) in 1999: 1 original PMA approval. All are in product code LMF (Agent, Absorbable Hemostatic, Collagen Based). 5 recalls are linked to its devices, 2 Class I.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Ferrosan Meidcal Devices A/S’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ferrosan Meidcal Devices A/S since 2007.

Recalls per year

1in 2024

2012: 3, 2 Class I2022: 12024: 1
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ferrosan Meidcal Devices A/S by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ferrosan”

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