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Amerx Healthcare Corp

United Statesfrom the FDA registration address FDA establishment FEI 3012535730

Devices
5
Registrations
FDA
FDA recalls
10

Catalogue5

Newest first, rows 1-5 of 5

Company details

FDA FEI number
3012535730
Address
164 Douglas Road East, Oldsmar, FL, 34677

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2016

    • 20 May 2016 Z-2249-2016 Class II Terminated Product did not meet specifications for Zinc Acetate (OOS). Distribution: AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain &…
      Full distribution text AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.
      Submission number: K970133

  • 2015

    • 25 Feb 2015 Z-1797-2015 Class II Terminated Nonapproved labeling claims (Sterile) Distribution: Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.
      Submission numbers: K970133, K971918

  • 2014

    • 26 Sep 2014 Z-0497-2015 Class II Terminated Formulation deviation Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
      Submission number: K971918
    • 26 Sep 2014 Z-0498-2015 Class II Terminated Formulation deviation Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
      Submission number: K971918
    • 26 Sep 2014 Z-0499-2015 Class II Terminated Formulation deviation Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
      Submission number: K971918
    • 26 Sep 2014 Z-0500-2015 Class II Terminated Formulation deviation Distribution: Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA,…
      Full distribution text Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.
      Submission number: K971918
    • 11 Jul 2014 Z-2638-2014 Class II Terminated Not approved labeling claims (antimicrobial and autolytic debridement) Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and…
      Full distribution text Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
      Submission number: K971918
    • 11 Jul 2014 Z-2639-2014 Class II Terminated Not approved labeling claims (antimicrobial and autolytic debridement) Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and…
      Full distribution text Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
      Submission number: K971918
    • 11 Jul 2014 Z-2640-2014 Class II Terminated Not approved labeling claims (antimicrobial and autolytic debridement) Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and…
      Full distribution text Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
      Submission number: K971918
    • 11 Jul 2014 Z-2641-2014 Class II Terminated Not approved labeling claims (antimicrobial and autolytic debridement) Distribution: Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and…
      Full distribution text Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.
      Submission number: K971918

Frequently asked questions

How many devices does Amerx Healthcare Corp have in the registry?

The registry currently lists 5 devices for Amerx Healthcare Corp. Devices recorded under merged duplicate company entries are counted once.

Which registries list Amerx Healthcare Corp's devices?

Among its 5 most recently registered devices, Amerx Healthcare Corp has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

Are there FDA recall records for Amerx Healthcare Corp?

FDA recall records list 10 recalls initiated by Amerx Healthcare Corp, the most recent initiated on 20 May 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Amerx Healthcare Corp in the registry?

The most recently registered devices listed for Amerx Healthcare Corp include Amerigel Saline Wound Wash 7175, Amerigel 1, AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE), MODEL A2027 and AMERIGEL OINTMENT.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.