FDA applicant

Elema-Schonander, Inc.

Mchenry, IL11 decisions1977–19930 recalls

FDA records 11 decisions for Elema-Schonander, Inc. (Mchenry, IL) from 1977 to 1993: 11 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and IZP (Programmer, Changer, Film/Cassette, Radiographic). 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 Elema-Schonander, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Elema-Schonander, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Elema-Schonander, Inc.

Which product codes does it file in?

What has FDA decided for it lately?