FDA applicant

Biosound Esaote, Inc.

Indianapolis, IN20 decisions1997–20030 recalls

FDA records 20 decisions for Biosound Esaote, Inc. (Indianapolis, IN) from 1997 to 2003: 20 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 22 predicates, 10 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Biosound Esaote, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biosound Esaote, 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 “Biosound”

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

Biosound, Inc. 39

Biosound Esaote, 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?

Other applicant names beginning “Biosound”