Data / Medical devices / United States / Amerx Healthcare Corp

Amerx Healthcare Corp: FDA-registered device maker in Oldsmar, FL, United States, 5 510(k) clearances

Name: Amerx Healthcare Corp FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Amerx Healthcare Corp is registered with the FDA (registration 3012535730) in Oldsmar, FL, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 26, 2012. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3012535730
Address: 164 Douglas Road East, Oldsmar, FL, United States, 34677
Owner or operator: Amerx Health Care Corporation (10029882)
Roles: Repackager or relabeler, Specification developer
First device listed: July 9, 2009
Registered through: 2026
Brand names listed: 1x3 fabric bandage 1.5x3 H Shaped Bandage, 1x5 cohesive wrap (flex tape), 2x2 non-sterile non-woven 4 ply gauze, Amerigel Ointment, Amerigel Ointment Saturated Wound D, Amerx Wound Wash, Bordered Gauze Dressing 1 x 1, Bordered Gauze Dressing 2 x 2 and more

Devices it lists

Device	Product code	Class	Role	Source
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	MGQ	U	Repackager or relabeler, Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Hydrophilic	NAC	1	Repackager or relabeler	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Repackager or relabeler	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Repackager or relabeler	accessdata.fda.gov
Lavage, Jet	FQH	2	Repackager or relabeler	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 26, 2012	K122325	SKINTEMP II	KGN	Substantially Equivalent	Human Biosciences, Inc.	accessdata.fda.gov
April 20, 2012	K112666	SALINE WOUND WASH	FRO	Substantially Equivalent	Nanoplas, Inc.	accessdata.fda.gov
June 17, 2009	K090848	PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM	FQH	Substantially Equivalent	Premier Brands of America, Inc.	accessdata.fda.gov
August 12, 1997	K971918	AMERIGEL OINTMENT SATURATED WOUND DRESSING	MGQ	Substantially Equivalent	Amerx Health Care Corp.	accessdata.fda.gov
April 14, 1997	K970133	AMERIGEL OINTMENT	MGQ	Substantially Equivalent for Some Indications	Amerx Health Care Corp.	accessdata.fda.gov

Compare with other makers

Updated October 26, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.