510(k) Report

FDA applicant

Scandimed. A.S.

Collegeville, PA2 decisions2003–20040 recalls

FDA records 2 decisions for Scandimed. A.S. (Collegeville, PA) from 2003 to 2004: 2 510(k) clearances. Most are in product codes FBK (Endoscopic Injection Needle…) and MND (Ligator, Esophageal). 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 Scandimed. A.S.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scandimed. A.S. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scandimed. A.S. 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?

  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision
  • MNDLigator, Esophageal1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K031236Auto-Band LigatorScandimed. A.S. · 20032cite it

What has FDA decided for it lately?

  • K031238Varices NeedleScandimed. A.S. · 2004
  • K031236Auto-Band LigatorScandimed. A.S. · 2003

All 2 as Scandimed. A.S. →

Other applicant names beginning “Scandimed.”

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

Scandimed International 2