510(k) Report

FDA applicant

Amerx Health Care Corp.

Clearwater, FL3 decisions1997–200912 recalls

FDA records 3 decisions for Amerx Health Care Corp. (Clearwater, FL) from 1997 to 2009: 3 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and SEJ (Wound Dressings Containing Topical Analgesics). Its devices cite 2 predicates, 1 of them its own earlier devices. 12 recalls are 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 Amerx Health Care Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2014: 102015: 12016: 1
2007high 10 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Amerx Health Care 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?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • SEJWound Dressings Containing Topical Analgesics1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G…Amerx Health Care Corp. · 20094cite it
  • K970133Amerigel OintmentAmerx Health Care Corp. · 19971cites it

What has FDA decided for it lately?

  • K092086Amerigel Wound Dressing Plus 1/2 OZ. (15G Tube), Model A2025; 1 OZ. (30G Tube), Model A2026; 3 OZ (90G…Amerx Health Care Corp. · 2009
  • K971918Amerigel Ointment Saturated Wound DressingAmerx Health Care Corp. · 199711 recalls
  • K970133Amerigel OintmentAmerx Health Care Corp. · 19972 recalls

All 3 as Amerx Health Care Corp. →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K970133Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.May 20, 2016Class II
  • K970133Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.Feb 25, 2015Class II
  • K971918Amerigel Daily Dressing Packets Wound managementSep 26, 2014Class II
  • K971918Amerigel Hydrogel Wound Dressing Wound managementSep 26, 2014Class II
  • K971918Amerigel Post-op Surgical Kits Wound managementSep 26, 2014Class II
  • K971918Amerigel Saturated Gauze Dressing Wound managementSep 26, 2014Class II