FDA applicant

Universal Medical, Inc.

Philadelphia, PA8 decisions1995–20080 recalls

FDA records 8 decisions for Universal Medical, Inc. (Philadelphia, PA) from 1995 to 2008: 8 510(k) clearances. All are in product code DXH (Transmitters And Receivers…). Its devices cite 4 predicates, 3 of them its own earlier devices. 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, cardiovascular panel, where it files most

How often FDA has decided Universal Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Universal Medical, 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?