510(k) Report

FDA applicant

Eastmed, Inc.

Dundas, CA2 decisions2008–20090 recalls

FDA records 2 decisions for Eastmed, Inc. (Dundas, CA) from 2008 to 2009: 2 510(k) clearances. All are in product code HHW (Pessary, Vaginal). Its devices cite 5 predicates, 1 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

1in 2009

2008: 12009: 1
2008high 1 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Eastmed, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eastmed, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HHWPessary, Vaginal2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 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.

  • K081385Uresta PessaryEastmed, Inc. · 20083cite it
  • K083769Modification to Uresta PessaryEastmed, Inc. · 20091cites it

What has FDA decided for it lately?

  • K083769Modification to Uresta PessaryEastmed, Inc. · 2009
  • K081385Uresta PessaryEastmed, Inc. · 2008

All 2 as Eastmed, Inc. →

Other applicant names beginning “Eastmed”

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

Eastmed Enterprises, Inc. 13