510(k) Report

FDA applicant

Xtramedics, Inc.

Deerfield, IL1 decision1989–19890 recalls

FDA records 1 decision for Xtramedics, Inc. (Deerfield, IL) in 1989: 1 510(k) clearance. All are in product code HEB (Tampon, Menstrual, Unscented). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Xtramedics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Xtramedics, Inc. 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?

  • HEBTampon, Menstrual, Unscented1decision

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.

  • K881384Interlabial PadXtramedics, Inc. · 19891cites it

What has FDA decided for it lately?

  • K881384Interlabial PadXtramedics, Inc. · 1989

The one decision as Xtramedics, Inc. →