FDA applicant

Merete GmbH

Berlin, DE2 decisions2017–20183 recalls

FDA records 2 decisions for Merete GmbH (Berlin, DE) from 2017 to 2018: 2 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2018

2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

3in 2020

2017high 3 (2020) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Merete GmbH by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Merete”

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

Merete Medical GmbH 25

Merete GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Merete”