510(k) Report

FDA applicant

Bay Shore Medical Equipment Corp.

Bay Shore, NY3 decisions1989–19920 recalls

FDA records 3 decisions for Bay Shore Medical Equipment Corp. (Bay Shore, NY) from 1989 to 1992: 3 510(k) clearances. Most are in product codes IZO (Generator, High-Voltage, X-Ray, Diagnostic) and IZH (System, X-Ray, Mammographic). 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 Bay Shore Medical Equipment Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bay Shore Medical Equipment Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bay Shore Medical Equipment Corp. 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?

  • IZOGenerator, High-Voltage, X-Ray, Diagnostic2decisions
  • IZHSystem, X-Ray, Mammographic1decision

What has FDA decided for it lately?

  • K922814TEC1410 Anatomical Programming Generator-ModificatBay Shore Medical Equipment Corp. · 1992
  • K904397TEC 1410Bay Shore Medical Equipment Corp. · 1990
  • K892342Tec 2750 Phoenix Dedicated Mammographic SystemBay Shore Medical Equipment Corp. · 1989

All 3 as Bay Shore Medical Equipment Corp. →