510(k) Report

FDA applicant

Haemacure Corp.

Sarasota, FL2 decisions2000–20040 recalls

FDA records 2 decisions for Haemacure Corp. (Sarasota, FL) from 2000 to 2004: 2 510(k) clearances. All are in product code FMF (Syringe, Piston). Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Haemacure Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Haemacure Corp. 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?

  • FMFSyringe, Piston2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K994023Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp. · 20002cite it

What has FDA decided for it lately?

  • K041504Hemamyst Surgical Applicator System, Model H-AS01Haemacure Corp. · 2004
  • K994023Haemacure Hemamyst Surgical Applicator System H-AS01Haemacure Corp. · 2000

All 2 as Haemacure Corp. →