510(k) Report

FDA applicant

Sodem Diffusion SA

North Attleboro, MA3 decisions1995–19970 recalls

FDA records 3 decisions for Sodem Diffusion SA (North Attleboro, MA) from 1995 to 1997: 3 510(k) clearances. Most are in product codes GET (Motor, Surgical Instrument, Pneumatic Powered) and HSZ (Instrument, Surgical, Orthopedic, Pneumatic…). Its devices cite 2 predicates, 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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Sodem Diffusion SA’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sodem Diffusion SA since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GETMotor, Surgical Instrument, Pneumatic Powered1decision
  • HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment1decision
  • HBBMotor, Drill, Pneumatic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K954717Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA · 19971cites it

What has FDA decided for it lately?

  • K954717Sodem High Speed System for Neurosurgery & Median SternotomySodem Diffusion SA · 1997
  • K955174Sodem High Speed System for Neurosurgery & Median StyernotomySodem Diffusion SA · 1996
  • K954080Sodem High Speed SystemSodem Diffusion SA · 1995

All 3 as Sodem Diffusion SA →