FDA applicant

Sonocare, Inc.

Saddle River, NJ2 decisions1988–19910 recalls

FDA records 2 decisions for Sonocare, Inc. (Saddle River, NJ) from 1988 to 1991: 1 510(k) clearance and 1 original PMA approval. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and LZR (Ultrasound, Cyclodestructive). 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Sonocare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Sonocare, Inc.

Which product codes does it file in?

What has FDA decided for it lately?