510(k) Report

FDA applicant

Aranz Medical Limited

Christchurch, Canterbury, NZ1 decision2007–20070 recalls

FDA records 1 decision for Aranz Medical Limited (Christchurch, Canterbury, NZ) in 2007: 1 510(k) clearance. All are in product code FXN (Tape, Camera, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Aranz Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • FXNTape, Camera, Surgical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070426Silhouette, Model 1000.01Aranz Medical Limited · 20071cites it

What has FDA decided for it lately?

  • K070426Silhouette, Model 1000.01Aranz Medical Limited · 2007

The one decision as Aranz Medical Limited →