International Medical Devices Database

Manufacturer Address
Ogenix Corporation, 3401 Enterprise Pkwy, Suite 340, Beachwood OH 44122-7341
Manufacturer Parent Company (2017)
Ogenix Corporation
Source
USFDA
1 Event
- Recall of EPIFLO

One device in the database

EPIFLO

Model / Serial
AL 041 (only lot involved); model EPIFLO-15.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including the states of FL, MN, OH and the county of Turkey.
Product Description
EPIFLO; Transdermal continuous oxygen therapy device; single use; disposable medical device. Model Number EPIFLO-15. Mfr.By: Neogenix, LLC, dba Ogenix, 3401 Enterprise Pkwy, Suite 340, Beachwood, OH 44122. || The EPIFLO System is intended to provide topical oxygen to treat 1.) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions 2.) Decubitus ulcers 3.) amputations/infected stumps 4.) skin grafts 5.) burns 6.) frostbite.

2 manufacturers with a similar name

Learn more about the data here

Microgenix Corporation

Manufacturer Parent Company (2017)
Thermo Fisher Scientific Inc
Source
FSSH

Ogenix Corporation

Manufacturer Address
Ogenix Corporation, 23230 Chagrin Blvd, Suite 950, Cleveland OH 44122-5461
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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