510(k) Report

FDA applicant

Hemo-Barrier Technologies, Inc.

Miami, FL1 decision1995–19950 recalls

FDA records 1 decision for Hemo-Barrier Technologies, Inc. (Miami, FL) in 1995: 1 510(k) clearance. All are in product code EFQ (Gauze/Sponge, Internal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Hemo-Barrier Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hemo-Barrier Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hemo-Barrier Technologies, 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?

  • EFQGauze/Sponge, Internal1decision

What has FDA decided for it lately?

  • K950258Hemo-Barrier TourniquetHemo-Barrier Technologies, Inc. · 1995

The one decision as Hemo-Barrier Technologies, Inc. →

Other applicant names beginning “Hemo-Barrier”

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

Hemo Sapiens, Inc. 2Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger 1