FDA applicant

Mermaid Medical A/S

Stenloese, DK1 decision2016–20160 recalls

FDA records 1 decision for Mermaid Medical A/S (Stenloese, DK) in 2016: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Mermaid Medical A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Mermaid Medical A/S by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mermaid Medical A/S’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 “Mermaid”

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

Mermaid Care A/S 1

Mermaid Medical A/S

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 “Mermaid”