FDA applicant

Medegen, Inc.

Ontario, CA1 decision2008–20082 recalls

FDA records 1 decision for Medegen, Inc. (Ontario, CA) in 2008: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). 2 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 Medegen, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2026

2008high 1 (2019) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Medegen, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medegen, Inc.’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 Medical Manufacturing System 2

Medegen, Inc.

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?

What has been recalled?

Other applicant names beginning “Medegen”