510(k) Report

FDA applicant

Quick-Med Technologies, Inc.

Gainesville, FL2 decisions2009–20130 recalls

FDA records 2 decisions for Quick-Med Technologies, Inc. (Gainesville, FL) from 2009 to 2013: 1 510(k) clearance and 1 De Novo grant. Most are in product codes NYS (Wound Dressing With Poly (Diallyl Dimethyl…) and FRL (Fiber, Medical, Absorbent). Its devices cite 2 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2013

2009: 12013: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Quick-Med Technologies, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NYSWound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride)(Pdadmac)1decision
  • FRLFiber, Medical, Absorbent1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K121898Stay Fresh Skin Fold Management TextileQuick-Med Technologies, Inc. · 2013
  • DEN070002QMT Nimbus Antimicrobial Barrier Gauze DressingQuick-Med Technologies, Inc. · 2009

All 2 as Quick-Med Technologies, Inc. →