510(k) Report

FDA applicant

Mint Medical GmbH

Dossenheim, DE1 decision2015–20153 recalls

FDA records 1 decision for Mint Medical GmbH (Dossenheim, DE) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, radiology panel, where it files most

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

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2026

2024: 22026 (partial year): 1
2015high 2 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Mint Medical GmbH by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mint Medical GmbH’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 “Mint”

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