510(k) Report

FDA applicant

Sonics & Materials, Inc.

Danbury, CT1 decision1997–19970 recalls

FDA records 1 decision for Sonics & Materials, Inc. (Danbury, CT) in 1997: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

FDA decisions per year

No FDA decision for Sonics & Materials, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sonics”

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