510(k) Report

FDA applicant

Croma-Pharma GmbH

Leobendorf2 decisions2025–20260 recalls

FDA records 2 decisions for Croma-Pharma GmbH (Leobendorf) from 2025 to 2026: 2 original PMA approvals. All are in product code LMH (Implant, Dermal, For Aesthetic Use). 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 Croma-Pharma GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Croma-Pharma GmbH by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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