510(k) Report

FDA applicant

Act Medical, Inc.

Waltham, MA2 decisions1996–19990 recalls

FDA records 2 decisions for Act Medical, Inc. (Waltham, MA) from 1996 to 1999: 2 510(k) clearances. Most are in product codes ODD (Endoscopic Retrograde Cholangiopancreatography…) and FPA (Set, Administration, Intravascular). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Act Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Act Medical, 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?

  • ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula1decision
  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K990693Flexneedle PlusAct Medical, Inc. · 1999
  • K953967Endoscopic CatheterAct Medical, Inc. · 1996

All 2 as Act Medical, Inc. →