FDA applicant

Merz North America, Inc.

Franksville7 decisions2005–20264 recalls

FDA records 7 decisions for Merz North America, Inc. (Franksville) from 2005 to 2026: 1 510(k) clearance and 6 original PMA approvals. Most are in product codes LMH (Implant, Dermal, For Aesthetic Use) and LNM (Agent, Bulking, Injectable For Gastro-Urology…). Its devices cite 1 predicate, 0 of them its own earlier devices. 4 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, general and plastic surgery panel, where it files most

How often FDA has decided Merz North America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 2 (2026) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Merz”

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

Merz Dental GmbH 9

Merz North America, Inc.

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 “Merz”