510(k) Report

FDA applicant

Misonix, LLC, A Bioventus Company

Farmingdale, NY1 decision2023–20230 recalls

FDA records 1 decision for Misonix, LLC, A Bioventus Company (Farmingdale, NY) in 2023: 1 510(k) clearance. All are in product code LFL (Instrument, Ultrasonic Surgical). Its devices cite 1 predicate, 0 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

How often FDA has decided Misonix, LLC, A Bioventus Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Misonix, LLC, A Bioventus Company by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LFLInstrument, Ultrasonic Surgical1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 20231cites it

What has FDA decided for it lately?

  • K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023

The one decision as Misonix, LLC, A Bioventus Company →

Other applicant names beginning “Misonix”

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

Misonix, Inc. 18