FDA applicant

Medegen Medical Manufacturing System

Ontario, CA2 decisions2005–20070 recalls

FDA records 2 decisions for Medegen Medical Manufacturing System (Ontario, CA) from 2005 to 2007: 2 510(k) clearances. All are in product code FPA (Set, Administration, Intravascular). 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 hospital panel, where it files most

How often FDA has decided Medegen Medical Manufacturing System’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medegen Medical Manufacturing System by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medegen Medical Manufacturing System’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 “Medegen”

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

Medegen Medical Manufacturing Services 5 Medegen, Inc. 1

Medegen Medical Manufacturing System

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medegen”