510(k) Report

FDA applicant

Myriad Ultrasound Systems, Ltd.

Rehovot1 decision1998–19980 recalls

FDA records 1 decision for Myriad Ultrasound Systems, Ltd. (Rehovot) in 1998: 1 original PMA approval. All are in product code MUA (Bone Sonometer). 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 Myriad Ultrasound Systems, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Myriad Ultrasound Systems, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Myriad”

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