510(k) Report

FDA applicant

Medworks Corp.

Pawtucket, RI3 decisions1998–19990 recalls

FDA records 3 decisions for Medworks Corp. (Pawtucket, RI) from 1998 to 1999: 3 510(k) clearances. Most are in product codes MFD (Cannula, Intrauterine Insemination) and EZL (Catheter, Retention Type, Balloon). Its devices cite 17 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Medworks Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • MFDCannula, Intrauterine Insemination2decisions
  • EZLCatheter, Retention Type, Balloon1decision

Whose devices does it build on?

Its devices cite 17 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.

  • K982628Medworks Insemination CatheterMedworks Corp. · 19981cites it

What has FDA decided for it lately?

  • K982630Medworks Visualization Insemination CatheterMedworks Corp. · 1999
  • K982628Medworks Insemination CatheterMedworks Corp. · 1998
  • K982626Urethropexy Suture Placement Kit Model Numbers UM-300, MW-100, Mini-Laparotomy MMK Kit Model UM-250…Medworks Corp. · 1998

All 3 as Medworks Corp. →