FDA applicant

Owen Mumford USA, Inc.

Marietta, GA10 decisions1995–20014 recalls

FDA records 10 decisions for Owen Mumford USA, Inc. (Marietta, GA) from 1995 to 2001: 10 510(k) clearances. Most are in product codes KZH (Introducer, Syringe Needle) and LKY (Device, External Penile Rigidity). Its devices cite 4 predicates, 2 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 hospital panel, where it files most

How often FDA has decided Owen Mumford USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Owen Mumford USA, Inc. since 2007.

Recalls per year

2in 2019

2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Owen Mumford USA, 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 “Owen”

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

Owen Mumford, Ltd. 13

Owen Mumford USA, Inc.

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?

What has been recalled?

Other applicant names beginning “Owen”