FDA applicant

Curasan AG

Kleinostheim, DE11 decisions1981–20180 recalls

FDA records 11 decisions for Curasan AG (Kleinostheim, DE) from 1981 to 2018: 10 510(k) clearances and 1 original PMA approval. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 18 predicates, 3 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, orthopedic panel, where it files most

How often FDA has decided Curasan AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 2 (2011) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Curasan AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Curasan”

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

Curasan Ag, Frankfurt Facility 1

Curasan AG

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 “Curasan”