FDA applicant

Omnisonics Medical Technologies

Wilmington, MA8 decisions1999–20080 recalls

FDA records 8 decisions for Omnisonics Medical Technologies (Wilmington, MA) from 1999 to 2008: 8 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and LFL (Instrument, Ultrasonic Surgical). Its devices cite 27 predicates, 4 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 Omnisonics Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Omnisonics Medical Technologies

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?